FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.
 ENFORCE
02/26/1991 

FDA Enforcement for the week of February 27, 1991 



                            FDA ENFORCEMENT REPORT
                                FOUARY 27, 1991 

                                                          February 27, 1991 
Recalls and Field Corrections:

                                     FOODS

                  Class I - A situation in which there is a reasonable
                  probability that the use of, or exposure to, a violative
                  Product will cause serious adverse health consequences or 
                  death.

                                     NONE 

                  Class II - A situation in which the use of, or exposure to
                  a violative product may cause temporary or medically
                  reversible adverse health consequences or where the 
                  probability of serious adverse health consequences is 
                  remote. 


Product:          Vineland Syrup brand beverage syrups: 
                  (a) Lemonade Flavor, in 1 gallon and 5 gallon containers; 
                  (b) Orange Flavor, in 1 gallon and 5 gallon containers. 
                  Recall #F-200/201-1.
Code:             Not coded.
Manufacturer:     Vineland Syrup, Inc., Vineland, New Jersey
Recalled by:      Manufacturer, by relabeling products on April 25, 1990. 
                  Firm-initiated field correction ongoing.

                                      -1- 






Distribution:     New Jersey, Pennsylvania, Delaware, Maryland. 
Quantity:         (a) 500 five gallon containers and 500 cases
                  (6 gallons/case); (b) 500 five gallon containers and
                  100 cases (6 gallons/case) were distributed.
Reason:           Products contain undeclared FD&C Yellow No. 5.

                                     ---- 

Product:          All packaged circle U kosher-designated shortening in 
                  50 lb. cubes and 380 lb. drums, used in the manufacture of
                  various bakery products, cake mixes, frostings, etc:
                  (a) MOA-07234 Cookie Shortening; partially hydrogenated 
                  soybean and cottonseed oils; spec # 11439, product code 
                  11439 (50 lb); Anderson Clayton/Humko Products, Inc., 
                  Memphis, TN 38101 
                  (b) Pillsbury 18821 Shortening; partially hydrogenated
                  soybean and cottonseed oils with mono- and diglycerides;
                  spec #666, product code 84206 (50 lb.) and 86192 (380 lb.)
                  Anderson Clayton/Humko Products, Inc., Memphis, TN 38101
                  (c) Pillsbury 18826 Shortening; partially hydrogenated
                  soybean oil, propylene glycol, mono- and diesters of fats,
                  mono- and diglycerides and lecithin; spec # 1179, product 
                  code 82091 (380 lb.); Anderson Clayton/Humko Products,
                  Inc., Memphis, TN 38101 
                  (d) Pillsbury 18897 Shortening; partially hydrogenated
                  soybean and cottonseed oils, BHA and citric acid added to 
                  preserve freshness; spec #635, product code 11440 
                  (50 lb.); Anderson Clayton/Humko Products, Inc., Memphis, 
                  TN 38101
                  (e) Pillsbury 18931 Shortening; vegetable oil blend, mono-
                  and diglycerides, propylene glycol, mono- and diesters of 
                  fats, polysorbate 60 not to exceed 1%, lecithin, BHA, BHT,
                  and citric acid added to help protect flavor; spec #1086, 
                  product code #10937 (380 lb.); Anderson Clayton/Humko 
                  Products, Inc., Memphis, TN 38101 
                  (f) Pillsbury 18935 Shortening; partially hydrogenated
                  soybean and cottonseed oils with artificial color; spec 
                  #983, product code 11616 (50 lb.); Anderson Clayton/Humko 
                  Products, Inc., Memphis, TN 38101 
                  (g) GMI Margarine Oil #6; partially hydrogenated soybean
                  and cottonseed oils with mono- and diglycerides added,
                  TBHQ and citric acid added to help preserve flavor, 
                  vitamin A palmitate added; spec #1169, product code 82095 
                  (50 lb.); Anderson Clayton/Humko Products, Inc., Memphis, 
                  TN 38101
                  (h) GMI Margarine Oil #7, code 3-343; partially 
                  hydrogenated soybean and cottonseed oils with mono- and 
                  diglycerides added, TBHQ and citric acid added to help
                  preserve flavor, vitamin A palmitate added; spec #1352, 
                  product code 11584 (50 lb.); Anderson Clayton/Humko 
                  Products, Inc., Memphis, TN 38101 
                  (i) GMI Margarine Oil #24, code 3-019; partially
                  hydrogenated soybean and cottonseed oils, mono- and 
                  diglycerides, BHA and BHT added to help protect flavor, 
                                      -2- 





                  vitamin A palmitate and vitamin D3 added; spec #1170, 
                  product code 82121 (50 lb.); Anderson Clayton/Humko 
                  Products, Inc., Memphis, TN 38101 
                  (j) GMI #56V Shortening, code 3-926; partially
                  hydrogenated soybean and cottonseed oils, propylene 
                  glycol mono- and diesters of fats, mono- and
                  diglycerides; spec #655, product code 81013 (50 lb.); 
                  Anderson Clayton/Humko Products, Inc., Memphis, TN 38101
                  (k) PS 12 Shortening; partially hydrogenated soybean oil; 
                  spec #636, product code 11051 (50 lb.); Anderson Clayton/ 
                  Humko Products, Inc., Memphis, TN 38101 
                  (l) PS 99 Icing Shortening; partially hydrogenated soybean
                  and palm oils with monoglycerides and diglycerides, 
                  polysorbate 60 not to exceed 1%, and lecithin added;
                  spec #648, product code 84216 (50 lb.); Anderson
                  Clayton/Humko Products, Inc., Memphis, TN 38101 
                  (m) PS 905 Icing Shortening; partially hydrogenated 
                  soybean and palm oils with monoglycerides and 
                  diglycerides, polysorbate 60 not to exceed 1%, lecithin,
                  TBHQ and citric acid; spec #838, product code 85594 
                  (50 lb.); Anderson Clayton/Humko Products, Inc., Memphis, 
                  TN 38101
                  (n) Chiffon Pure Vegetable Icing Shortening; partially
                  hydrogenated soybean and cottonseed oils with 
                  monoglycerides and diglycerides, polysorbate 60 not to
                  exceed 1%, and lecithin added; spec #642, product codes 
                  81488 and 11403 (50 lb.); Anderson Clayton/Humko
                  Products, Inc., Memphis, TN 38101 
                  (o) Hazelwood Farms Vegetable Icing Shortening; partially 
                  hydrogenated soybean and cottonseed oils with 
                  monoglycerides and diglycerides, polysorbate 60 not to
                  exceed 1% and lecithin added; product code 81735
                  (50 lb.); Distributed by Hazelwood Farms Bakeries, Inc.,
                  Hazelwood, MO 
                  (p) Karp's All Purpose Shortening; partially hydrogenated 
                  soybean and cottonseed oils; spec #821, product code 84010
                  (50 lb.); Distributed by Karp's Bakers Supplies,
                  Minneapolis, MN 55344 
                  (q) Vegetable Shortening with Lecithin #0073; partially 
                  hydrogenated soybean oil with lecithin; spec # 1413,
                  product code 11903 (50 lb.) and spec #1274, product code
                  10952 (50 lb.); Anderson Clayton/Humko Products, Inc.,
                  Memphis, TN 38101;
                  (r) Partially hydrogenated soybean oil with TBHQ, citric
                  acid and dimethylpolysiloxane added; spec #632
                  i) product code #81556 (50 lb.); Kerba Pure Vegetable 
                  Frying Shortening; Anderson Clayton/Humko Products, Inc., 
                  Dist., Memphis, TN 38101; 
                  ii) product code #83280 (50 lb.); Chiffon Heavy Duty Pure 
                  Vegetable Frying Shortening; Anderson Clayton/Humko 
                  Products, Inc., Dist., Memphis, TN 38101; 
                  iii) product code #82650 (50 lb.); Karp's Vegetable 
                  Frying Shortening; Dist. by Karp's Bakers Supplies, 
                  Milwaukee, WI 53204;

                                      -3- 





                  (s) Partially Hydrogenated soybean and cottonseed oils; 
                  spec #821,
                  i) product code #11528 (50 lb.); Unifax All Purpose 
                  Vegetable Shortening; Unifax, Inc., Wilkes-Barre, PA 18702; 
                  ii) product code #81986 (50 lb.); Red & White All Purpose 
                  Shortening; Dist. by Red & White International, Park
                  Ridge, IL 60068;
                  iii) product code #81984 (50 lb.); Pocahontas Vegetable All 
                  Purpose Shortening; Dist. by Pocahontas Food Brokers, 
                  Richmond, VA 23228; 
                  iv) product code #11406 (50 lb.); PS 857 Shortening;
                  Anderson Clayton/Humko Products, Inc. Dist., Memphis TN;
                  v) product code #81705 (50 lb.); Hazlewood Farms Vegetable
                  all Purpose Shortening; Dist. by Hazlewood Farms Bakeries,
                  Inc., Hazlewood, MO 63042.  Recall #F-202/218-1, F-226/227-1. 
Code:             All kosher-designated shortening produced between 
                  November 18, 1990 and January 7, 1991.  Lot numbers 322JOH
                  through 365JOH, and 001J1H through 007J1H.
Manufacturer:     Kraft Food Ingredients Corp. Jacksonville, Illinois.
Recalled by:      Kraft food Ingredients Corporation, formerly known as 
                  Anderson Clayton/Humko Products, Inc., Memphis, Tennessee, by 
                  telephone January 9-10, 1991 followed by letter January 
                  14, 1991.  Firm-initiated recall ongoing. 
Distribution:     Nationwide. 
Quantity:         2,651,610 pounds were distributed; firm estimates 20
                  percent remains on the market.
Reason:           Products are contaminated with metal particles. 

                                     ---- 

                  Class III - A situation in which the use of, or exposure
                  to a violative product is not likely to cause adverse 
                  health consequences.

Product:          Single Serving Size Ketchup under Dixie Crystals, NIFDA,
                  Vend Rite, Hermitage, Ketchup La Touraine labels. 
                  Recall #F-156-1.
Code:             The individual serving size pouches are not coded.
                  Each case contains an imprint of a code number and
                  packaging date on the tape used to seal the case: 
                  9/10/90  11365; 9/10/90  11390; 9/10/90  11392; 
                  9/11/90  11350; 9/11/90  11351; 9/11/90  11390; 
                  9/11/90  11355; 9/11/90  11392; 9/12/90  11342; 
                  9/12/90  11355; 9/12/90  11360; 9/12/90  11362; 
                  9/12/90  11392; 9/13/90  11342; 9/13/90  11344; 
                  9/13/90  11357; 9/13/90  11392; 9/14/90  11342; 
                  9/15/90  11356; 9/15/90  11355; 9/14/90  11355; 
                  9/14/90  11357; 9/17/90  11341; 9/17/90  11342; 
                  9/17/90  11354; 9/17/90  11357; 9/17/90  11364; 
                  9/17/90  11365; 9/18/90  11340; 9/18/90  11341; 
                  9/18/90  11342; 9/18/90  11350, 9/18/90  11354; 
                  9/18/90  11392; 9/19/90  11344; 9/19/90  11345; 
                  9/19/90  11355; 9/19/90  11362; 9/19/90  11392; 
                  9/20/90  11340; 9/20/90  11344; 9/20/90  11345; 
                                      -4- 





                  9/20/90  11355; 9/20/90  11362; 9/20/90  11364; 
                  9/21/90  11345; 9/21/90  11355; 9/21/90  11362. 
Manufacturer:     Savannah Foodservice of Florida Inc., Miami, Florida. 
Recalled by:      Savannah Foods & Industries, Inc., Savannah, Georgia, by
                  telephone October 25, 1990.  Firm-initiated recall complete.
Distribution:     Nationwide. 
Quantity:         22,757 cases were distributed.
Reason:           Product is contaminated with mold.

                                     ---- 

Product:          Hinckley & Schmitt brand bottled water in 1 gallon
                  plastic jugs: 
                  (a) Drinking Water; (b) Distilled Water; (c) Nursery
                  Water.  Recall #F-193/195-1.
Code:             Lot numbers:  32390, 32490, 32590.
Manufacturer:     Hinckley & Schmitt, Inc., Chicago, Illinois.
Recalled by:      Manufacturer, by letter December 4, 1990.  Firm-initiated 
                  recall ongoing. 
Distribution:     Illinois, Wisconsin.
Reason:           Product is contaminated with styrene. 

                                     ---- 

Product:          Franco's brand Frozen Conch Meat, in 5 pound boxes. 
                  Recall #F-219-1.
Code:             Not coded.
Manufacturer:     B & D Fishing, Ltd., Kingston, Jamaica, W.I.
Recalled by:      E & M Seafood Distributors, Inc., Miami, Florida, by
                  telephone November 15, 1990.  Firm-initiated recall 
                  ongoing.
Distribution:     Florida, Puerto Rico, Canada. 
Quantity:         1,754 fifty pound cases were distributed. 
Reason:           Product is decomposed.

                                     ---- 

Product:          (a) Western Family Reduced Calorie Lite Syrup Product,
                  in 24 fluid ounce bottles;
                  (b) Fred Meyer Lite Syrup Product, in 24 fluid ounce
                  bottles.  Recall #F-220/221-1.
Code:             All lots. 
Manufacturer:     Hoody Corporation, Beaverton, Oregon. 
Recalled by:      Manufacturer, by telephone December 12, 1990 followed 
                  by letter December 13, 1990.  Firm-initiated recall 
                  ongoing.
Distribution:     Oregon, Washington state, Arizona, Hawaii, Montana, Utah. 
Quantity:         3,800 cases (12 bottles/case) were distributed. 
Reason:           Product is contaminated with yeast. 

                                     ---- 

                                      -5- 





                                   COSMETICS

                                     NONE 

                           HUMAN DRUGS AND BIOLOGICS

                  Class I - 

Product:          Indocin Ophthalmic Solution, 1%, an Rx product. 
                  Recall #D-190-1.
Code:             Not coded.
Manufacturer:     Hieber's Drug Store, Pittsburgh, Pennsylvania.
Recalled by:      Manufacturer, by telephone November 2, 1990 followed by 
                  letter.  Firm-initiated recall complete.
Distribution:     Pennsylvania, Ohio, West Virginia.
Quantity:         Approximately 1,300 bottles were distributed. 
Reason:           Bacterial contamination with Pseudomonas aeruginosa.

                                     ---- 
                  Class II -

Product:          Methylprednisolone Tablets, USP 4 mg, in 100 and 500 tablet 
                  bottles, an Rx product used for treating endocrine and
                  rheumatic disorders, under Aligen, Best, Bioline, Dixon,
                  Duramed, Genetco, Geneva, Glenlawn, Goldline, Harber, 
                  Major, MedServ, Moore, Par-Med, Qualitest, Rugby, Schein, 
                  and URL labels.  Recall #D-179-1. 
Code:             Lot numbers 80152 to 92535 EXP 1/91-9/93. 
Manufacturer:     Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by:      Manufacturer, by letter January 4 and 14, 1991. 
                  Firm-initiated recall ongoing.
Distribution:     Nationwide. 
Quantity:         73 lots (approximately 69,350,000 tablets) were 
                  distributed.
Reason:           The drug was not manufactured in accordance with the
                  approved Abbreviated New Drug Application specifications. 

                                     ---- 

Product:          Hydroxyzine Pamoate Capsules, USP, 25, 50 and 100 mg, 
                  in 100, 500 and 1,000 capsule bottles, an Rx product
                  used to relieve anxiety and tension, under
                  Aligen, Best, Bioline, Duramed, Genetco, Goldline,
                  Major, Moore, Par-Med, Qualitest, Rugby, Schein, and
                  URL labels.  Recall #D-180/182-1. 
Code:             All lots. 
Manufacturer:     Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by:      Manufacturer, by letter January 8 and 14, 1991. 
                  Firm-initiated recall ongoing.
Distribution:     Nationwide. 
Quantity:         169 lots containing approximately 950,000 capsules
                  per lot were distributed. 

                                      -6- 





Reason:           The product was not manufactured in accordance with 
                  approved Abbreviated New Drug Application specifications. 

                                     ---- 

Product:          Clonidine Hydrochloride Tablets, USP, 0.1 mg, 0.2 mg, 
                  0.3 mg, in bottles of 100, 500 and 1,000 tablets, an
                  Rx product used for treating hypertension, under the Best,
                  Bioline, Duramed, Genetco, Glenlawn, Goldline, Mason, 
                  Parmed, Qualitest, Rugby, and URL labels. 
                  Recall #D-183/185-1.
Code:             All lots. 
Manufacturer:     Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by:      Manufacturer, by letter January 8 and 14, 1991. 
                  Firm-initiated recall ongoing.
Distribution:     Nationwide. 
Quantity:         109 lots were distributed.
Reason:           The product was not manufactured in accordance with 
                  approved Abbreviated New Drug Application specifications. 

                                     ---- 

Product:          Trifluoperazine Hydrochloride Tablets, USP, 
                  (a) 1 mg; (b) 2 mg; (c) 5 mg; (d) 10 mg, in 100, 500 and
                  1,000 tablet bottles, an Rx product used to treat 
                  psychotic disorders, under Aligen, Best, Bioline, Dixon's,
                  Duramed, Genetco, Goldline, Harber, Major, Moore, Par-Med,
                  Purepac, Qualitest, Rugby, Schein, URL. 
                  Recall #D-186/189-1.
Code:             All lots. 
Manufacturer:     Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by:      Manufacturer, by letter January 14, 1991.  Firm-initiated 
                  recall ongoing. 
Distribution:     Nationwide. 
Quantity:         37 lots containing approximately 950,000 tablets were 
                  distributed.
Reason:           The product was not manufactured in accordance with 
                  approved Abbreviated New Drug Application specification.

                                     ---- 

Product:          Lederle brand Albuterol Sulfate Tablets, 4 mg, in 
                  bottles of 100, an Rx bronchodilator.  Recall #D-191-1. 
Code:             Lot #280-227 EXP 2/92.
Manufacturer:     Lederle Laboratories, Pearle River, New York. 
Recalled by:      Manufacturer, by letter January 1991.  Firm-initiated 
                  recall ongoing. 
Distribution:     Nationwide. 
Quantity:         9,694 bottles were distributed. 
Reason:           Product failed USP dissolution specifications.

                                     ---- 

                                      -7- 





Product:          Trifluoperazine HC1 Tablets: (a) 2 mg; (b) 5 mg;
                  (c) 10 mg, in unit dose blister packages of 100 (10 strips
                  of 10 tablets each), an Rx product used for the management
                  of the manifestations of psychotic disorders. 
                  Recall #D-192/194-1.
Code:             Lot numbers:  (a) OJ637 EXP 1/92; (b) OI606 EXP 6/92, 
                  OP063 EXP 4/92; (c) OH521 EXP 5/92, and OJ695 EXP 7/92. 
Manufacturer:     Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by:      UDL Laboratories, Inc., Rockford, Illinois (repacker), by 
                  letter January 23, 1991.  Firm-initiated recall ongoing.
Distribution:     Nationwide. 
Quantity:         14,930 unit cartons were distributed; firm estimates 40%
                  of the product remains on the market. 
Reason:           The product was not manufactured in accordance with 
                  approved Abbreviated New Drug Application specifications. 

                                     ---- 

Product:          Docusate Sodium Solution, 100 mg, 10 ml unit dose cups, 
                  10 cups per tray, an OTC stool softener.  Recall #D-195-1.
Code:             Lot number 003006 EXP 3/92. 
Manufacturer:     UDL Laboratories, Inc., Largo, Florida. 
Recalled by:      UDL Laboratories, Inc., Rockford, Illinois, by letter 
                  January 22, 1991.  Firm-initiated field correction ongoing. 
Distribution:     Nationwide. 
Quantity:         4,022 cases were distributed; firm estimates 30% of the 
                  product remains on the market.
Reason:           Some of the trays labeled as Docusate Sodium Solution,
                  contained some unit dose cups labeled as Guaifenesin DM 
                  Syrup mixed with the Docusate Sodium Solution unit dose 
                  cups. 
                                     ---- 

Product:          GHB (Gamma Hydroxy Butyrate) Granules, 60 gm and 100 gm 
                  bottles, an OTC product promoted as a growth hormone
                  stimulant which worked during sleep, under the Biosky 
                  Research Group and Advanced Performance labels. 
                  Recall #D-198-1.
Code:             All lots. 
Manufacturer:     Champion Distributors, Horsham, Pennsylvania. 
Recalled by:      Manufacturer, by visit and by telephone January 29, 1991
                  followed by letter.  Firm-initiated recall complete.
Distribution:     Pennsylvania, Delaware, New Jersey. 
Quantity:         253 bottles were distributed. 
Reason:           Product marketed without new drug approval.  See also 
                  FDA press release P90-53, November 8, 1990. 

                                     ---- 

Product:          Tru-Tar Therapeutic Protein Shampoo, in 8 ounce bottles,
                  an OTC product used to treat dandruff and psoriasis.
                  Recall #D-199-1.
Code:             Lot #G-266 EXP 9/93.

                                      -8- 





Manufacturer:     Syosset Laboratories Company, Inc., Syosset, New York.
Recalled by:      Manufacturer, by telephone October 18, 1990 and by letter 
                  October 24, 1990.  Firm-initiated recall ongoing. 
Distribution:     Alabama, Arizona, California, Georgia, Illinois, Michigan,
                  New Jersey, New York, Ohio, Pennsylvania, Texas.
Quantity:         3,862 bottles were distributed; firm estimates less than
                  750 bottles remain on the market. 
Reason:           Product is contaminated with Pseudomonas aeruginosa.

                                     ---- 

Product:          (a) Red Blood Cells; (b) Platelets; (c) Recovered 
                  Plasma.  Recall #B-114/116-1. 
Code:             Unit numbers:  (a) 17F03849; (b) 17P77181; (c) 17F03849.
Manufacturer:     American Red Cross, St. Paul, Minnesota.
Recalled by:      Manufacturer, by telephone January 8, 1990. 
                  Firm-initiated recall complete. 
Distribution:     (a) Wisconsin; (b&c) Minnesota. 
Quantity:         1 unit of each component. 
Reason:           Blood products collected from donors who engaged in 
                  high risk behavior were distributed.

                                     ---- 

Product:          (a) Red Blood Cells; (b) Platelets; 
                  (c) Cryoprecipitated AHF; (d) Recovered Plasma. 
                  Recall #B-117/120-1.
Code:             Unit numbers: (a) 04F43781, 04G26669, 04G28860, 04G30611, 
                  04M85796, 04Y70893, 04Y83085, 04LE03380, 04LE04663, 
                  04LE10711, 04LE16431; (b) 04F43781, 04Y70893; 
                  (c) 04G30611; (d) 04F43781, 04G26669, 04G28860, 04G30611, 
                  04M85796, 04Y70893, 04Y83085, 04LE03380, 04LE04663, 
                  04LE10711, 04LEl6431. 
Manufacturer:     American Red Cross, Dedham, Massachusetts.
Recalled by:      Manufacturer, by telephone October 18, 1990 followed by 
                  letter November 1, 1990.  Firm-initiated recall ongoing.
Distribution:     Maine, Massachusetts, California, Switzerland.
Quantity:         (a) 11 units; (b) 2 units; (c) 1 unit; (d) 11 units.
Reason:           Blood products which were non-reactive for anti-HIV-1,
                  but collected from a donor who previously tested
                  repeatably reactive for anti-HIV-1, were distributed. 

                                     ---- 
                   Class III -

Product:          Clorazepate Dipotassium Tablets:
                  (a) 3.75 mg; (b) 7.5 mg; (c) 15 mg, under the following 
                  labels:  American Therapeutics, Best Generics,
                  Bioline, Dixon Shane, H.L. Moore Drug Exchange, Qualitest 
                  Schein, Goldline, Harber, Major, Martec, Parmed 
                  Rugby.  Recall #D-176/178-1.
Code:             Lot No.      EXP. DATE
                  (a) 010027    1/92
                      910313    10/91 

                                      -9- 





                      907208    7/91
                      906195    6/91
                      901012    1/91
                      811318    11/90 
                      810273    10/90 
                  (b) 912406    12/91 
                      908270    8/91
                      908269    8/91
                      907214    7/91
                      906191    6/91
                      904086    4/91
                      901022    1/91
                      901020    1/91
                      812373    12/90 
                      811330    11/90 
                  (c) 010017    1/92
                      910314    10/91 
                      906192    6/91
                      901021    1/91
                      812350    12/90 
Manufacturer:     American Therapeutics, Inc., Bohemia, New York. 
Recalled by:      Manufacturer, by letter on or about October 22, 1990. 
                  Firm-initiated recall ongoing.
Distribution:     Nationwide and Puerto Rico. 
Quantity:         Lot number      Bottles shipped 
                                  100's     500's    1000's 

                  (a) 010027      3,864     3,021     54
                      910313       11,424    1,611    24
                      907208       6,588     2,551    48
                      906195       8,520     2,076    82
                      901012       7,853     2,148    97
                      811318       8,616     2,240     0
                      810273       10,581    1,860     0
                  (b) 912406       7,111     2,280    108 
                      908270       7,197     2,456      0 
                      908269       10,109    1,728     96 
                      907214       5,069     2,879     24 
                      906191       10,656    1,729     48 
                      904086       4,250     3,048     18 
                      901022       8,020     2,316      0 
                      901020       2,856     3,336      0 
                      812373       7,444     2,485      0 
                      811330       9,689     2,016      0 
                  (c) 010017       144       1,906      0 
                      910314       4,104     144      498 
                      906192       6,486       360    160 
                      901021       2,592       1,462    0 
                      812350       8,256       239      0 
Reason:           The product is exhibiting crumbling.

                                     ---- 

                                     -10- 





Product:          Conjugated Estrogens Tablets, (a) 0.3 mg in bottles 
                  of 100, under the Zenith, Major and URL labels; 
                  (b) 2.5 mg. in bottles of 100 and 1,000, under the
                  Zenith and Major labels, an Rx product used for the 
                  treatment of symptoms of menopause, postmenopausal
                  osteoporosis and breast swelling after pregnancy. 
                  Recall #D-196/197-1.
Code:             Lot numbers: (a) 3636-26 EXP 3/91; (b) 2160-46 EXP 3/91.
Manufacturer:     Zenith Laboratories, Inc., Northvale, New Jersey. 
Recalled by:      Manufacturer, by telephone January 15, 1991 followed
                  by letter January 17, 1991.  Firm-initiated recall
                  ongoing.
Distribution:     Nationwide. 
Quantity:         (a) 9,365 bottles of 100; (b) 921,100 tablets were
                  distributed.
Reason:           Products do not meet content uniformity specifications. 

                                     ---- 

Product:          Bulk Ibuprofen, in 70 kg drums, an Rx.  Recall #D-200-1.
Code:             All lots between LPL 1198 and LPL 1223 inclusive. 
Manufacturer:     Ethyl Corporation, Oreangeburg, South Carolina. 
Recalled by:      Ethyl Corporation, Baton Rouge, Louisiana, by telephone 
                  September 14 and 27, 1990 and October 3, 1990.
                  Firm-initiated recall ongoing.
Distribution:     Michigan, New York, New Jersey, Puerto Rico, Belgium. 
Quantity:         112,471 kg were distributed; firm estimates 80,000 kg 
                  remain on the market. 
Reason:           The product was found to have metal/rubber contamination. 

                                     ---- 

Product:          (a) Red Blood Cells; (b) Plasma.  Recall #B-075/076-1.
Code:             Unit numbers:  (a) 40GN36142, 40GT78632; 40LE00428, 
                  40LE00429; (b) 40LE00428, 40LE00429.
Manufacturer:     American Red Cross Blood Services, Peoria, Illinois.
Recalled by:      Manufacturer, by telephone May 31, 1990.  Firm-initiated
                  recall complete.
Distribution:     (a) Illinois; (b) Missouri. 
Quantity:         (a) 4 units; (b) 2 units. 
Reason:           Blood products labeled with incorrect expiration dates
                  were distributed. 
                                     ---- 

Product:          Reagent Red Blood Cells Spectrogen-Trio.  Recall #B-126-1.
Code:             Lot #90440, Cell III EXP 11/16/90.
Manufacturer:     Organon Teknika Corporation, West Chester, Pennsylvania.
Recalled by:      Manufacturer, by letter October 22, 1990.  Firm-initiated 
                  recall ocomplete
Distribution:     Nationwide and international. 
Quantity:         699 kits were distributed; firm estimates none remains
                  on the market.
Reason:           Lu(a-) Reagent Red Blood Cells labeled as Lu (a+) were
                  distributed.
                                     ---- 
                                     -11- 





Product:          Reagent Red Blood Cells; Search-Cyte TCS. 
                  Recall #B-137-1.
Code:             Lot #CET-3-85 EXP 9/22/90.
Manufacturer:     Baxter Healthcare Corporation, Miami, Florida.
Recalled by:      Manufacturer, by letter September 17, 1990.  Firm-
                  initiated recall complete.
Distribution:     Nationwide and international. 
Quantity:         495 kits were distributed; firm estimates none remains
                  on the market.
Reason:           Le(a+b+) Reagent Red Blood Cells labeled Le(a-b+) 
                  were distributed. 
                                     ---- 

                         MEDICAL DEVICES AND RADIOLOGY

                  Class I - 

Product:          Respiration/Heart Rate Monitors, used to monitor patients 
                  who are at risk from central apnea, fast heart rate or slow 
                  heart rate: 
                  (a) Model 9200; (b) Model 9200/50 (International);
                  (c) Model 9200/70 (CSA); (d) Model 9500;
                  (e) Model 9550.  Recall #Z-155/159-1. 
Code:             Serial Number Range: (a) 360615-361397; 
                  (b) 450046-450072; (c) 400323-400375
                  (d) 455002-455056; (e) 429160-429183. 
Manufacturer:     Aequitron Medical, Inc., Plymouth, Minnesota. 
Recalled by:      Manufacturer, by letter November 23, 1990.  Firm-initiated
                  recall ongoing. 
Distribution:     Nationwide, Spain, West Germany, Canada.
Quantity:         867 devices were distributed. 
Reason:           Mechanical shock may cause the audible alarm to 
                  malfunction.  This failure mode can result in a "NO ALARM"
                  condition.
                                     ---- 

Product:          Flexiflo Sacks-Vine Gastrostomy PEG (percutaneous endoscopic
                  gastrostomy) Kits, used for the feeding of patients 
                  unable to consume food through the mouth: 
                  (a) 14 French Basic Kit, Catalog #226;
                  (b) 14 French Complete Kit, Catalog #227; 
                  (c) 18 French Basic Kit, Catalog #228;
                  (d) 18 French Complete Kit, Catalog #238. 
                  Recall #Z-196/199-1.
Code:             Lot numbers: (a) 42-347-GZ through 47-479-GZ; 
                  (b) 41-340-GZ through 47-484-GZ;
                  (c) 41-327-GZ through 46-469-GZ;
                  (d) 41-334-GZ through 46-464-GZ.
Manufacturer:     Ross Laboratories, Division of Abbott Laboratories, Inc., 
                  Columbus, Ohio. 
Recalled by:      Manufacturer, by telephone November 21, 1990, followed
                  by letter.  Firm-initiated recall ongoing.
Distribution:     Nationwide and international. 
Quantity:         Approximately 18,010 kits were distributed; firm
                  estimates 5,500 remain on the market. 
                                     -12- 





Reason:           The gastrostomy tube bumper, which is implanted to the
                  inside of the gastric wall, and serves as the connection for
                  the feeding tube, may be pulled through the gastric wall, 
                  allowing the stomach to fall away from the anterior 
                  abdominal wall.  This separation can go undetected, allowing
                  the food to enter peritoneal cavity.

                                     ---- 
                  Class II -

Product:          (a & b) Brace Denture Adhesive Cream in 1.4 ounce and 2.4 
                  ounce tubes under Norcliff Thayer, Inc or SmithKline
                  Beecham Corp. label;
                  (c - e) Orafix  Special Denture Adhesive, in .5 ounce,
                  1.4 ounce, 2.4 ounce and 3.8 ounce tubes under the Norcliff 
                  Thayer, Inc., SmithKline Beecham Corp. or Beecham Products
                  U.S.A. labels.  Recall #Z-247/251-1.
Code:             All lots. 
Manufacturer:     SmithKline Beecham Consumer Brands, St. Louis, Missouri.
Recalled by:      SmithKline Beecham Consumer Brands, Pittsburgh, 
                  Pennsylvania, by mailgram December 27, 1990 and by press
                  release December 28, 1990.  Firm-initiated recall ongoing.
                  See also FDA press release P90-64, December 27, 1990. 
Distribution:     Nationwide and international. 
Quantity:         (a&b) 146,000 units; (c-e) 1,466,000 units were distributed.
Reason:           Products contain a unacceptable level of benzene, a known 
                  carcinogen. 
                                     ---- 

Product:          Cushion Grip Denture Adhesive, in .25 ounce, .50 ounce and
                  1.0 ounce metal tubes.  Recall #Z-254-1.
Code:             All lots. 
Manufacturer:     Schering-Plough Healthcare Products, Inc., Memphis, 
                  Tennessee.
Recalled by:      Manufacturer, by press release December 28, 1990 and by 
                  letter december 29, 1990.  Firm-initiated recall ongoing. 
                  See also FDA press release P90-64, December 27 1990.
Distribution:     Nationwide and Canada.
Quantity:         Firm estimates 180,000 to 240,000 tubes of each retail
                  size may remain on the market.
Reason:           Product contain an unacceptable level of benzene, a 
                  known carcinogen. 
                                     ---- 

Product:          Posterior, Mod-C Biconvex, UV Absorbing, 6.5 mm Optic,
                  2-hole Intraocular Lens with Blue PMMA Loops. 
                  Recall #Z-262-1.
Code:             All six digit Alpha-numeric serial numbers beginning with 
                  "EU" and all eight digit Alpha-numeric catalog numbers
                  beginning with "48-25". 
Manufacturer:     3M Vision Care, Goleta, California. 
Recalled by:      Manufacturer, by telephone followed by letter 
                  August 10, 1990.  Firm-initiated recall ongoing.
Distribution:     Nationwide, Singapore, Australia. 

                                     -13- 





Quantity:         404 lenses were distributed.
Reason:           The inner package is labeled as the lens having an optic
                  diameter of 6.0 mm, while the optic diameter is actually
                  6.5 mm.  The outer package/box is correctly labeled.

                                     ---- 

Product:          Chemstrip bG Test Strips, Catalog #00502, used with 
                  Accu-Chek II and IIm Monitors for self-testing of blood 
                  sugar (glucose) by diabetics.  Recall #Z-278-1. 
Code:             Lot #252146 EXP 10/1/91.
Manufacturer:     Boehringer Mannheim America Ltd., Ponce, Puerto Rico. 
Recalled by:      Boehringer Mannheim Corporation, Indianapolis, Indiana, 
                  by letters sent between  September 27, 1989 to October 5, 
                  1989.  Firm-initiated recall complete.
Distribution:     Nationwide. 
Quantity:         96,002 vials of 50 test strips were distributed; firm 
                  estimates none remains on the market. 
Reason:           This lot was exposed to high temperature during 
                  transportation which caused shrinkage of the container cap
                  resulting in a loose-seal which led to absorption of
                  moisture affecting the product performance. 

                                     ---- 

Product:          Tomographic Tables used for all Sopha camera systems. 
                  Recall #Z-284-1.
Code:             All tables not manufactured with the new process which is 
                  currently being determined by the firm. 
Manufacturer:     Stratline, Paris, France. 
Recalled by:      Sopha Medical Systems Columbia, Maryland, by visit
                  not yet initiated.
Distribution:     Nationwide. 
Quantity:         322 tables were distributed.
Reason:           The tables may break during use exposing patients to injury 
                  from the fall to the floor. 

                                     ---- 

Product:          (a) All Purpose Instrument Tray, Catalog #24008-020;
                  (b) Suture Removal Tray, Catalog #24000-005.
                  Recall #Z-285/286-1.
Code:             Lot numbers:  (a) DOK809 EXP 5/92; (b) DOK811.
Manufacturer:     Baxter Healthcare Corporation, Johnson City, Tennessee. 
Recalled by:      Baxter Healthcare Corporation, Deerfield, Illinois, by
                  letter December 20, 1990.  Firm-initiated recall ongoing. 
Distribution:     Nationwide. 
Quantity:         (a) 5,000; (b) 39,000 units were distributed. 
Reason:           The trays were assembled using thumb forceps subject to 
                  recalls Z-089/092-1.  A reddish-brown greasy residue may form 
                  on the surface when the instruments are ETO sterilized. 

                                     ---- 

                                     -14- 





                  Class III - 

Product:          Contact lenses: 
                  (a) Bi-Soft; (b) Cibasoft; (c) Cibasoft (Visitent); 
                  (d) Focus; (e) Newvues; (f) Softcolors, STD Cibasoft; 
                  (g) Cibathin; (h) Softcon Daily Wear; (i) Softcon EW; 
                  (j) Spectrum Bifocal; (k) Spectrum Toric; 
                  (l) Spectrum Visitint; (m) STD (Cibasoft);
                  (n) STD (Visitint); (o) Torisoft.  Recall #Z-263/277-1. 
Code:             Lot numbers:  (a) 104363; 
                  (b) 983619, 101313, 104363, 107221, 871202; 
                  (c) 105156, 983619; (d) 115069; 
                  (e) 961920, 992826, 991422, 100118, 100402, 100237, 
                      100364, 104467, 104165, 105269, 105147; 
                  (f) 105156, 107221, 102347, 105156; 
                  (g) 107221, 871202; (h) 972745; (i) 110490; 
                  (j) 106330, 111485; (k) 110414, 990853, 102277, 106317; 
                  (l) 961904, 981118, 105077, 105457; (m) 107221; 
                  (n) 102347, 871202, 105156; (o) 046482. 
Manufacturer:     Ciba Vision Corporation, Atlanta, Georgia.
Recalled by:      Manufacturer, by letter November 30, 1990.  Firm-initiated
                  recall complete.
Distribution:     Nationwide and international. 
Quantity:         Amounts distributed: (a) 356; (b) 13,857; (c) 9,067;
                  (d) 1,275; (e) 61,581; (f) 4,828; (g) 1,493;
                  (h) 235; (i) 283; (j) 1,492; (k) 1,863; (l) 12,416; 
                  (m) 653; (n) 5,028; (o) 1,267.
Reason:           The lenses are labeled to the wrong power.

                                     ---- 

                              VETERINARY PRODUCTS 

                                     NONE