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
09/29/1993
Recalls and Field Corrections: Foods -- Class I -- 09/29/1993
September 29, 1993 93-39
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Willie B's canned sauce and dip products:
(a) Premium Texas Caviar (black-eyed pea dip), in 8 ounce
and 16 ounce jars;
(b) Salsa Con-queso, in 8 ounce and 16 ounce glass jars.
Recall #F-631\632-3.
CODE All lots.
MANUFACTURER Willie B's World Famous Hot Sauce, Rockwall, Texas.
RECALLED BY Manufacturer, by telephone August 13-14, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 196 cases of 8 ounce jars and 1,580 cases of 16 ounce
jars (12 jars per case); (b) 15 cases of 8 ounce jars and
1,534 cases of 16 ounce jars (12 jars per case).
REASON Product has the potential to support the growth of
Clostridium botulinum toxin.
_______________
PRODUCT Vanilla Flavored Ice Cream Sandwiches. Recall #F-645-3.
CODE Lot #160194.
MANUFACTURER Dairy Mart, Cuyahoga Falls, Ohio.
RECALLED BY Manufacturer, by voice mail June 12, 1993, with follow-up
Fax on June 14, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Ohio, Kentucky, New England.
QUANTITY 34,752 ice cream bars were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Hand Crafted Pottery: (a) Canisters; (b) Plates (various
sizes); (c) Mugs; (d) Cups (various sizes).
Recall #F-641/644-3.
CODE None. The potter usually signs her initials, MM.
MANUFACTURER Marge Margulies Pottery, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by telephone July 7, 1993, followed by letter
July 8, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON Product contains excessive levels of leachable lead.
_______________
PRODUCT Sunnydale Farms Pina Colada Drink, in 1/2 gallon size
containers. Recall #F-636-3.
CODE Sell by date Aug 17, Aug 24, Aug 31 and Sept 8.
MANUFACTURER Sunnydale Farms, Brooklyn, New York.
RECALLED BY Manufacturer, by telephone August 13, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION New York, New Jersey.
QUANTITY Approximately 850 cases with sell by date Aug 17, 683 cases
with sell by date Aug 24, 467 cases with sell by date of Aug
31, and 343 cases with sell by date of Sept 8. Each case
contains 12 half-gallon units.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Kellogg Eggo Minis Homestyle Miniature Waffles, packed with
on-pack coupons, in 12 ounce cartons. Recall #F-637-3.
CODE Lot numbers: A1543, A1553, A1583, A1653, A1663, A1673,
A1683, A1963, A1973, A2033, A2013, A2023, A2033, A2043,
J1933, J1943, J1953, J1963, J1973, J2003, J2013, J2023,
J2033.
MANUFACTURER Mrs. Smith's Frozen Foods Company, San Jose, California;
Mrs. Smith's Frozen Foods Company, Atlanta, Georgia.
RECALLED BY Mrs. Smith's Frozen Foods Company, Inc., Pottstown,
Pennsylvania, by letter July 30, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, The Bahamas, Mexico.
QUANTITY 38,508 cases (12 units per case) were distributed; firm
estimates approximately 20,000 cases remain on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
-2- _______________
PRODUCT Fresh Frozen Hash Brown Potatoes, Southern Style (diced),
packaged in two pound bags, under True Value and Bonnie
Hubbard labels. Recall #F-640-3.
CODE Lot #030521.
MANUFACTURER McCain Foods, Inc., Othello, Washington.
RECALLED BY Manufacturer, by telephone June 24, 1993. Firm-initiated
recall complete.
DISTRIBUTION Arizona, California, Utah.
QUANTITY 384 cases (12 bags per case) were distributed.
REASON Product is contaminated with salmonella.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Lawry's Garlic Spread Concentrate, in 4 ounce cars.
Recall #F-574-3.
CODE 2K24M.
MANUFACTURER Lipton, Company, Independence, Missouri.
RECALLED BY Lipton Company, Englewood Cliffs, New Jersey, by letter May
19, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 11,176 cases (12 jars per case) were distributed; firm
estimates none remains on the market.
REASON Product was contaminated with mold.
_______________
PRODUCT Willie B's canned sauce and dip products:
(a) Salsa Verde (green sauce), in 16 ounce glass jars;
(b) World Famous Hot Sauce, in 8 ounce and 16 ounce glass
jars. Recall #F-633/634-3.
CODE All lots manufactured prior to August 10, 1993.
MANUFACTURER Willie B's World Famous Hot Sauce, Rockwall, Texas.
RECALLED BY Manufacturer, by telephone August 13-14, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 358 cases (12 jars per case); (b) 543 cases of 8 ounce
jars and 3,498 cases of 16 ounce jars (12 jars per case)
were distributed.
REASON Products were manufactured without adequate records to
demonstrate proper thermal processing.
_______________
PRODUCT Celebrity brand Mandarin Oranges in 11 ounce cans.
Recall #F-638-3.
CODE All codes.
MANUFACTURER Unknown. Product of China. Imported by: Atlanta
Corporation, Elizabeth, New Jersey.
RECALLED BY Food Lion, Inc., Salisbury, North Carolina, by electronic
mail March 22, 1993. Firm-initiated recall complete.
DISTRIBUTION North Carolina, Virginia, South Carolina, Florida,
Tennessee, Pennsylvania, Texas.
-3- QUANTITY Firm estimated that 1,600 cases remained on the market at
time of recall.
REASON Product is in swollen cans.
_______________
PRODUCT Entera Complete Liquid Nutrition Mocha Artificial Flavor, in
8 ounce brikpaks, for use as a dietary supplement or as the
total diet. Recall #F-639-3.
CODE Lot #C1OAV.
MANUFACTURER Beatrice Foods, Inc., Brampton, Ontario, Canada.
RECALLED BY Fresenius Pharma USA, Inc., New Brunswick, New Jersey, by
telephone August 20, 1992, and by letter August 25, 1993.
Firm-initiated recall complete.
DISTRIBUTION Colorado, Connecticut, Georgia, Massachusetts, Maryland,
Michigan, Missouri, New York, Ohio, Pennsylvania, New
Jersey, South Carolina.
QUANTITY 598 cases (12 units per case) were distributed.
REASON Product is subpotent in Vitamin B-12.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Nitroglycerin Extended Release Capsules, (a) 6.5 mg;
(b) 2.5 mg both packaged in 60 and 100-capsule bottles, for
the prevention of angina pectoris due to coronary artery
disease. Recall #D-340/341-3.
CODE 6.5 mg, 60-capsule bottle - Lot #V3117, EXP 3/95
6.5 mg, 100-capsule bottle - Lot #V2706, EXP 1/95
#V2887, EXP 1/95, #V2888, EXP 1/95
#V2891, EXP 2/95, #V2892, EXP 2/95
#V2893, EXP 2/95, #V2895, EXP 2/95
#V2896, EXP 2/95, #V2897, EXP 3/95
#V2898, EXP 3/95, #V3091, EXP 3/95
2.5 mg, 60-capsule bottle - Lot #V1433, EXP 2/94
#V2250, Exp. 8/94, #V2747, EXP 11/94
2.5 mg, 100-capsule bottle - Lot #V2501, EXP 12/94
#V2504, EXP 12/94, #V3005, EXP 1/95
MANUFACTURER KV Pharmaceutical Company, St. Louis, Missouri.
RECALLED BY Ethex Corporation, St. Louis, Missouri, by letter September
17, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 417 cases (12 60-capsule bottles per case) and 781 cases
(12 100-capsule bottles per case); (b) 3,801 cases (12 60-
capsule bottles per case) and 159 cases (12 100-capsule
bottles per case were distributed.
REASON Lack of adequate assurance of potency through expiration
date.
_______________
PRODUCT Papaverine HCL Time Release Capsules, 150 mg, Rx, in 100 and
1000 capsule bottles, under Schein and Danbury labels.
Recall #D-342-3.
-4- CODE Lot numbers: 41517D EXP 11/93, 41368D EXP 9/93, 41675D EXP
1/94, 42021D EXP 5/94.
MANUFACTURER Danbury Pharmacal, Inc., Danbury, Connecticut.
RECALLED BY Manufacturer, by letter September 9, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Lot #41517D estimated 200 100-capsule bottles under the
Danbury Pharmacal Inc. Label;
Estimated 25 1000-capsule bottles under the Danbury
Pharmacal Inc. label;
Lot #41368D estimated 10 100-capsule bottles under the
Schein Pharmaceutical Inc. label;
Estimated 20 100-capsule bottles under the Danbury Pharmacal
Inc. label;
Estimated 2 1000-capsule bottles under the Schein
Pharmaceutical Inc. label;
Lot #41675D estimated 1000 100-capsule bottles under the
Danbury Pharmacal Inc. label;
Estimated 35 1000-capsule bottles under the Danbury
Pharmacal Inc. label;
Lot #42021D estimated 4000 100-capsule bottles under the
Danbury Pharmacal Inc. label.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Procainamide HCl Extended Release Tablets, 750 mg, in
bottles of 100 and 500, Rx, under Schein and Danbury labels.
Recall #D-343-3.
CODE Lot #43761D EXP 3/95.
MANUFACTURER Danbury Pharmacal, Inc., Danbury, Connecticut.
RECALLED BY Manufacturer, by letter September 9, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 700 100-tablet bottles and 200 500-tablet bottles were
distributed.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Transfilled Compressed Oxygen, in E, D, 80 cubic feet, M,
and N cylinders. Recall #D-344-3.
CODE All codes, all lots and all fill dates.
MANUFACTURER SBL Home Medical Equipment, Ronkonkoma, New York (repacker).
RECALLED BY Repacker, by visit beginning September 16, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 218 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
-5- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Natus Patch, Pain Relief Patches for fast, temporary relief
of pain, containing methyl salicylate 11 %, menthol 2%, and
camphor 3.5%, in boxes of 30. Recall #D-339-3.
CODE All lots.
MANUFACTURER LecTec Corporation, Minnetonka, Minnesota.
RECALLED BY Natus Corporation, Edina, Minnesota, by letter September 15,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 271,350 units were distributed.
REASON Potency not assured through expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-236/238-3.
CODE Unit numbers: (a) 114326; (b) 114326; (c) 117728.
MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, Alaska.
RECALLED BY Manufacturer, by telephone December 3, 1992, and by letter
dated February 19, 1993. Firm-initiated recall complete.
DISTRIBUTION Alaska, Florida.
QUANTITY 1 unit of each component.
REASON Blood products which were either: 1) collected from an
ineligible donor due to the application of a tattoo less
than 12 months prior to donation; or 2) untested for all
required and recommended viral markers, were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-324-3.
CODE Unit #8353174.
MANUFACTURER The Blood Center for Southeast LA, New Orleans, Louisiana.
RECALLED BY Manufacturer, by facsimile on February 1, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product which tested repeatedly reactive for the
antibody to the hepatitis C virus encoded antigen (anti-
HCV), was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-422-3.
CODE Units 01H21352 and 01X31262.
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
RECALLED BY Manufacturer, by letters of July 28, 1992, and December 29,
1992. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 2 units.
REASON Blood products collected from ineligible donors due to
travel in areas endemic for malaria were distributed.
-6- _______________
PRODUCT Platelets. Recall #B-438-3.
CODE Unit #60J30624.
MANUFACTURER American Red Cross Blood Services, Miami, Florida.
RECALLED BY Manufacturer, by telephone August 7, 1992. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product, collected from an ineligible donor due to the
application of a tattoo less than 12 months prior to
donation, was distributed.
_______________
PRODUCT Source Plasma. Recall #B-439-3.
CODE Units 107691 and 107696.
MANUFACTURER DCI Plasma Center of Duluth, Inc., Duluth, Minnesota.
RECALLED BY Manufacturer, by facsimile dated March 30, 1993. Firm-
initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 2 units.
REASON Blood products, which tested repeatedly reactive for the
antibody to hepatitis C virus encoded antigen (anti-HCV),
were distributed.
_______________
PRODUCT Platelets. Recall #B-440-3.
CODE Unit numbers: 6530361, 6530362, 6530364.
MANUFACTURER Blood Center of Southeast Texas, Inc. (BCST), Beaumont,
Texas.
RECALLED BY Manufacturer, by telephone May 14, 1993. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 3 units.
REASON Blood products labeled with incorrect expiration dates were
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-437-3.
CODE Unit numbers: 7712877, 7712878, 9702922, 9702941, 9703464,
9703478, 9703479, 9703483, 9703491, 9703492, 9704529,
9704678, 9704936.
MANUFACTURER Sylvan N. Goldman Center, doing business as Oklahoma Blood
Institute (OBI), Oklahoma City, Oklahoma.
RECALLED BY Manufacturer, telephone February 17, 18 and March 29, 1993.
Firm-initiated recall complete.
DISTRIBUTION Michigan, Louisiana, Massachusetts, California.
QUANTITY 13 units.
REASON Unlicensed blood products were distributed interstate.
-7- _______________
PRODUCT Red Blood Cells. Recall #B-441-3.
CODE Unit numbers: 6207742, 6207743, 6207746.
MANUFACTURER Blood Center of Southeast Texas, Inc. (BCST), Beaumont,
Texas.
RECALLED BY Manufacturer, by visit December 23, 1992. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 3 units.
REASON Blood products labeled with incorrect expiration dates were
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells, Washed;
(c) Platelets; (d) Fresh Frozen Plasma;
(e) Recovered Plasma. Recall #B-448/452-3.
CODE Unit numbers: (a) N30122, N30138, N69925, N75778, N78621,
N81923, N82599, N83278, N89093, N95824, N96191, Q01125,
Q03769, Q05434, Q09190, Q09327, Q10685, Q17304; (b) N95959;
(c) N75778, N78621, N82599, N89093, N95824, N95959, N96191,
Q03769, Q05434; (d) N75778, N89093; (e) N69925, N78621,
N81923, N82599, N95824, N95959, N96191, Q01125, Q03769,
Q05434, Q09190, Q09327, Q17304.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by letters with response forms dated July 26,
1993. Firm-initiated recall complete.
DISTRIBUTION Illinois, Indiana, California, New York, New Jersey.
QUANTITY (a) 18 units; (b) 1 unit; (c) 9 units; (d) 2 units;
(e) 13 units.
REASON Blood products incorrectly tested for syphilis were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICE -- CLASS II
========================
_______________
PRODUCT Mevatron 6 and 12 Clinical Linear Accelerators with x-ray
fields, designed for radiotherapy treatments:
Recall #Z-644/645-3.
CODE Mevatron 6 and 12 with the following serial numbers for
those units which are in service or in storage:
Mevatron 6 -- 1061, 1062, 1063, 1064, 1066, 1068, 1076,
1079, 1081, 1083, 1084, 1096, 1097, 1098, 1099, 1106, 1107,
1108, and 1109.
Mevatron 12 -- 1055, 1056, 1069, 1071, 1072, 1073, 1077,
1078, 1082, 1087, 1088, 1089, 1091, 1092, 1093, 1094, 1101,
1102, 1103, 1104, 1111, 1112, 1113, 1114, 1116, 1117, 1118,
and 1119.
MANUFACTURER Siemens Medical Laboratories, Inc., Concord, California.
RECALLED BY Manufacturer, by inspection of April 1992. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
-8- QUANTITY 54 units were distributed.
REASON The devices were distributed without an appropriate
maintenance schedule for the lead counter weight.
_______________
PRODUCT Photon ERA Software, Versions 3.8, 3.8MD, 4.01 and Photon
ERA-QA Software, Versions 1.01:
(a) Model 20100001, Photon ERA-QA Automated Immunoassay
Analyzer; (b) Model 9R1001, Photon ERA Automated Immunoassay
Analyzer; (c) Model 99800, Photon ERA Automated Immunoassay
Analyzer. Recall #Z-680/682-3.
CODE Model numbers: 20100001, 9R1001, 99800.
MANUFACTURER Hybritech, Inc., San Diego, California.
RECALLED BY Manufacturer, February 28, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 769 software packages were distributed.
REASON There are two software problems which in some cases could
lead to incorrect calculation of patient results on photon
ERA assays.
_______________
PRODUCT USCI Semi-Floating Bipolar Transvenous Electrode, 4F, used
to transmit a pacing electrical stimulus from the pulse
generator to the heart and/or transmit an electrical signal
from the heart to A recording device. Recall #Z-765-3.
CODE Item #006221, lot #07CB7153.
MANUFACTURER USCI Division, C.R. Bard, Inc., Glen Falls, New York.
RECALLED BY USCI Division of C.R. Bard, Inc., Billerica, Massachusetts,
by telephone January 27, 1993, and by letter dated January
27, 1993. Firm-initiated recall complete.
DISTRIBUTION California, North Carolina, New York
QUANTITY 70 units were distributed.
REASON Product labeled as sterile was not sterilized.
_______________
PRODUCT SBT-100 Rectal Suction Biopsy Tool, used to obtain a rectal
biopsy specimen to establish the presence of ganglion cells
in infants and children. Recall #Z-785-3.
CODE All serial numbers.
MANUFACTURER Trewavis Surgical Ltd., Victoria, Australia.
RECALLED BY Medical Measurements, Inc., Hackensack, New Jersey, by
telephone beginning on or about December 1, 1992. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 115 units were distributed.
REASON Product did not contain adequate directions for use.
-9- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Performance Fixation Pins, Rx, nonsterile pins used to hold
the tibial cutting block in place during surgery.
Recall #Z-495-3.
CODE Catalog #9904-00-004, lot #011363.
MANUFACTURER Kirschner Medical Corporation, Timonium, Maryland.
RECALLED BY Kirschner Medical Corporation, Fair Lawn, New Jersey, by
telephone and by letters dated November 10, 1992, and
December 2, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 12 units were distributed.
REASON Some product labeled as Performance Fixation Pins actually
contained Total Condylar Pin Fixation Pins.
_______________
PRODUCT KMP Modular Fenestrated Moore-type Femoral Stem Component,
for use in hip implantation. Recall #Z-679-3.
CODE Catalog #5713-32-160, lot #003893.
MANUFACTURER Kirschner Medical Corporation, Timonium, Maryland.
RECALLED BY Kirschner Medical Corporation, Fair Lawn, New Jersey, by
telephone January 8, 1993, followed by letter dated January
12, 1993. Firm-initiated recall complete.
DISTRIBUTION Maryland, Tennessee, Alabama, Florida, Texas, Mississippi.
QUANTITY 5 units were distributed.
REASON Labeling mix-up. A solid straight stem product was packaged
and labeled as a fenestrated femoral stem product.
_______________
PRODUCT Catheter Repair Kits. These kits contain certain lots of
Dow Corning Silastic brand 7-2947 Medical Adhesive Silicone
Type A - Sterile which are currently being recalled by Dow
Corning. Recall Z-709/720-3.
CODE Catalog No. Repair Kit for
0601600 1.5mm Lumen Broviac Catheter
0601610 0.7mm Lumen Broviac Catheter
0601620 1.0mm Lumen Broviac Catheter
0601630 1.6mm Lumen Hickman Catheter
0601680 White Adapter Leg of Hickman and
Leonard Dual Lumen and Hickman
Triple Lumen Catheters
0601690 Red Adapter Leg of Hickman and Leonard
Dual Lumen and Hickman Triple Lumen
Catheters
0601700 External Catheter Segment of Hickman
12 Fr. Catheters.
0601720 Medical Grade Adhesive Kit for Catheter
Repair
0601740 External Catheter Segment of Leonard
10 Fr. Catheter
0601750 External Catheter Segment of Leonard 10
Fr. Catheter
-10- 0601760 External Catheter Segment of Hickman 7 Fr.
Catheter
7741800 Groshong 8.0 Fr. Catheter.
MANUFACTURER Bard Access Systems, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by letter dated April 5, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,613 kits were distributed.
REASON Kits contain adhesive that did not meet the sterility
assurance level.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
====================
_______________
PRODUCT (a) Xenodine, Polyhydroxydine Solution, in 1 fluid ounce and
8 fluid ounce plastic squeeze bottles, OTC, for use as a
topical microbicide on animals;
(b) Xenodine Spray, Polyhydroxydine Solution, in 12 fluid
ounce plastic bottles, OTC, for use as a topical microbicide
on dogs, cats, horses and farm animals.
Recall #V-042/043-3.
CODES (a) 9L39436, 9L39447, OD46909, OK49172, 1F59498, 2D61774,
9L39003, 0B47018, 0D47509, 0J46091, 0L49953, 1E56924, MEMOO,
MFMO1, MKMO2; (b) 0939370, 9M38992, 0E46271, 0M47560,
1B58441, 1D57556, 1E56517, MLM03, MCE04, MEE05.
MANUFACTURER Bristol-Myers Squibb Company, New Brunswick, New Jersey;
Bristol-Myers Squibb Company, Humacao, Puerto Rico;
Bristol-Myers Squibb Company, Evansville, Indiana.
RECALLED BY Solvay Animal Health, Inc., Charles City, Iowa, by letters
dated July 30, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, West Indies, Canada.
QUANTITY Approximately (a) 263,097 1-fluid ounce bottles, and 65,738
8-fluid ounce bottles; (b) Approximately 53,213 bottles were
distributed.
REASON Product is an unapproved new animal drug. Adverse drug
reactions and the lack of a warning statement on the
labeling warning against the use of product on cats and
kittens.
_______________
PRODUCT Furosemide Veterinary 50 mg Tablets, and 12.5 mg Tablets,
packaged in amber glass bottles containing 500 tablets, Rx
diuretic for veterinary use only in dogs:
(a) Furosemide Tablets, 50 mg and 12.5 mg, under Biocraft
label; (b) Furosemide Tablets, 50 mg under Henry Schein
label; (c) Furosemide Tablets, 50 mg, under Burns Veterinary
Supply label; (d) Furosemide Tablets, 50 mg and 12.5 mg,
under Phoenix Pharmaceuticals label. Recall #V-044/047-3.
CODE Lot #'s: 14987, 16048, 16049, 16059, 16060, 16061, 16062,
16411, 16429, 16519, 16550, 16551, 16552, 16553, 16631,
16632, 16633, 16634, 16635.
MANUFACTURER Biocraft Laboratories, Inc, Paterson, New Jersey.
-11- RECALLED BY Biocraft Laboratories, Inc., Fairlawn, New Jersey, by
telephone, followed by letter March 1993, and on or about
May 27, 1993 through June 4, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Amount Shipped:
Lot# Amt. of Bottles Total Tablets
100's 500's
14987 4112 2797 1,089,700
16048 9440 0 944,000
16049 0 1957 978,500
16059 3443 3443 1,322,800
16060 7272 2000 1,727,200
16061 0 1901 950,500
16062 0 1807 903,500
16411 0 1932 966,000
16429 0 3164 1,582,000
16519 0 1856 928,000
16550 0 960 480,000
16551 0 965 482,500
16552 0 3907 1,953,500
16553 0 2931 1,465,500
16631 0 905 452,500
16632 0 950 475,000
16633 0 965 482,500
16634 0 3888 1,944,000
16635 0 3936 1,968,000.
REASON Superpotent and subpotent products.
_______________
PRODUCT CU 5 Steer 40, pelleted medicated feed containing Rumensin.
Recall #V-053-3.
CODE 3629CX2.
MANUFACTURER Purina Mills, Inc., Lincoln, Nebraska.
RECALLED BY Purina Mills, Inc., St. Louis, Missouri, by telephone April
5, 1993. Firm-initiated recall complete.
DISTRIBUTION Nebraska.
QUANTITY 5,935 pounds were distributed.
REASON Feed subpotent in monensin and melengestrol acetate (MGA)
due to mixer operator error.
-12-
END OF ENFORCEMENT REPORT FOR SEPTEMBER 29, 1993. BLANK PAGES MAY
FOLLOW.
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