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
03/26/1991
FDA Enforcement for the week of March 27, 1991
FDA ENFORCEMENT REPORT
FOR MARCH 27, 1991
March 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.
Product: All products containing manufactured L-tryptophan
produced by Showa Denko K.K. Recall #F-199-1.
Code: All lots.
Manufacturer: All manufacturers and distributors.
Recalled by: All manufacturers and distributors. FDA-requested recall
ongoing.
Distribution: Nationwide.
Quantity: Unknown.
Reason: Products contain L-tryptophan manufactured by the
firm, Showa Denko, which has been shown to be associated
with the development of eosinophilia-myalgia syndrome.
----
-1-
Product: Submarine Sandwich, net weight 3-1/2 ounces, microwave
setting C, packaged in a polypropylene overwrap with a
yellow stick-on label. Recall #F-294-1.
Code: 15048.
Manufacturer: Stewart Sandwiches, Inc., Norfolk, Virginia.
Recalled by: Manufacturer, by telephone and by letter June 11, 1990.
Firm-initiated recall complete.
Distribution: Southeastern United States.
Quantity: 303 cases (18,180 units) were distributed.
Reason: Product is contaminated with Listeria monocytogenes.
----
Product: Southern Belle Sandwich brand ready to eat sandwiches:
(a) Twin Dog Sandwich (two hot dogs), 8 ounces;
(b) Hot Dog with chili Sandwich, 4 ounces.
Recall #F-295/296-1.
Code: Pull dates: (a) 02, 05, 06, 08, 09, K12 or 12, K13 or
13, and K15 or 15;
(b) 02, 08, 12, and K13 or 13.
Manufacturer: Southern Belle Sandwich Company, Inc., Baton Rouge,
Louisiana.
Recalled by: Manufacturer, by letter November 6, 1990. Firm-initiated
recall ongoing.
Distribution: (a) Louisiana, Florida, Mississippi, Alabama;
(b) Louisiana.
Quantity: (a) 5,756 units; (b) 560 units were distributed; firm
estimates none remains on the market.
Reason: Product is contaminated with Listeria monocytogenes.
----
Product: Smooth Pimento Cheese Spread in 7, 12 and 24 ounce rigid
plastic containers. Recall #F-297-1.
Code: FEB 15 on the bottom of the container.
Manufacturer: Stratton Foods, Inc., Clearwater, Florida.
Recalled by: Manufacturer, by telephone February 1, 1991 and by
press release. Firm-initiated recall ongoing.
Distribution: Southeastern United States.
Quantity: 130 cases (12/7 ounce); 73 cases (6/12 oz) and 39 cases
(6/24 oz) containers per case.
Reason: Product is contaminated with Listeria monocytogenes.
----
Product: Frozen, Canned, Cooked Crabmeat, in 5 pound cans
labeled in part, "Harbor Bell Quality fresh Dungeness
Crab Meat". Recall #F-298-1.
Code: 117D.
Manufacturer: Harbor Bell Seafoods, Bay Center, Washington.
Recalled by: Manufacturer, by telephone followed by visit February 19,
1991. Firm-initiated recall ongoing.
Distribution: California.
Quantity: 27 cases (6 cans/case) were distributed.
-2-
Reason: Product is contaminated with Listeria monocytogenes.
----
Product: Imitation Breaded Scallops, frozen, in 2.2 pound boxes.
Recall #F-299-1.
Code: Lot #28690, Order #405002.
Manufacturer: Chunil, Seoul, Korea.
Recalled by: Miwon USA, Inc., Moonachie, New Jersey (importer), by
letter September 19, 1990. Firm-initiated recall ongoing.
Distribution: New York, New Jersey.
Quantity: 50 cases (10 boxes/case) were distributed.
Reason: Product is contaminated with Listeria monocytogenes.
----
CORRECTION: Recall #F-228-1, which appeared in the March 13, 1991
Enforcement Report should read:
Product: Queso Panela Cheese, packed in 7 ounce, 13 ounce,
14 ounce, 16 ounce and bulk packages, under
Rancho Grande, Vaquero and El Mexicano labels.
The other products listed in the March 13, 1991
Enforcement Report are not subject to recall.
----
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.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Erythromycin Ethylsuccinate Oral Suspension USP 200 mg,
in pint size plastic bottles, an Rx antibiotic.
Recall #D-279-1.
-3-
Code: Lot numbers 92395 EXP 7/91, 92631 EXP 9/91.
Manufacturer: Barre National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter January 28, 1991. Firm-
initiated recall ongoing.
Distribution: Nationwide and Puerto Rico.
Quantity: 71,364 bottles of lot #92395 and 79,018 bottles of
lot 92631 were distributed.
Reason: Product does not meet viscosity specifications which
may affect suspension characteristics.
----
Product: Walgreens Wal-tussin DM Expectorant, Cough Suppressant,
Guaifenesin 100 mg and Dextromethorphan Hydrobromide 10
mg., in 4 fluid ounce glass bottles, an oral OTC product.
Recall #D-282-1.
Code: Lot #OSFW EXP 10/92.
Manufacturer: Xcel Laboratories, Inc., Chicago, Illinois.
Recalled by: Xcel Laboratories, Inc., Elmhurst, Illinois, by
telephone February 22, 1991 followed by letter March
4, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 14,892 bottles were distributed; firm estimates 30%
of product distributed remain on market.
Reason: Some of the bottles were mislabeled as Walgreens Wal-tussin
Expectorant, which contains only Guaifenesin. The
mislabeled bottles were then placed in correctly labeled
Walgreens Wal-tussin DM boxes.
----
Product: Amantadine HCl Capsules, 100 mg, in containers of 100,
250, 500 and 1000, an Rx product used as an anti-parkinson
and anti-viral therapy, under Bolar, Baxter, American
Preferred, Rugby, Parmed, J.J. Balan and Warner Chilcott
labels. Recall #D-284-1.
Code: All lots.
Manufacturer: Pharmacaps, Inc., Elizabeth, New Jersey.
Recalled by: Bolar Pharmaceutical Company, Inc., Copiague, New York,
by letter February 11, 1991. Firm-initiated recall
ongoing.
Distribution: Nationwide and Puerto Rico.
Quantity: Firm estimates 500,000 capsules remain on the market.
Reason: Equipment used to manufacture was different than that
identified in the Abbreviated New Drug Application.
----
Product: Omnipen-N (Ampicillin Sodium) Injection, in 2 gram
add vantage vials, an Rx sterile powder for reconstituted
IV administration. Recall #D-287-1.
Code: Lot #2900293 EXP 4/93.
Manufacturer: Wyeth-Ayerst Labs, West Chester, Pennsylvania.
Recalled by: Wyeth-Ayerst Labs, St. Davids, Pennsylvania, by
letter March 13, 1991. Firm-initiated recall ongoing.
-4-
Distribution: Nationwide.
Quantity: 14,415 packages of 10 were distributed; firm estimates
1,000 packages remain on the market.
Reason: Lack of assurance of sterility.
----
Product: Simetyl Suspension, in 1 fluid ounce and 4 fluid
ounce bottles, an OTC product used as an antiflatulent,
antispasmodic and anticholinergic, distributed by
Kramer Pharmacal, Inc. Recall #D-290-1.
Code: Lot numbers 891220 EXP 7/92, 900712 EXP 2/93.
Manufacturer: Lex, Inc., Medley, Florida.
Recalled by: Manufacturer, by letter on or about March 8, 1991.
Firm-initiated recall ongoing.
Distribution: Puerto Rico.
Quantity: 9,432 bottles of lot 891220 and 6,012 bottles of
lot 900712 were distributed; firm estimates none
remains on the market.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Mardrops, Liquid Cold Remedy and Expectorant, in 10
ounce amber glass bottles, an OTC product for
symptomatic relief of coughing and nasal and bronchial
congestion, distributed by Marlop Pharmaceutical Inc.
Recall #D-291-1.
Code: Lot #900510 EXP 11/92.
Manufacturer: Lex, Inc., Medley, Florida.
Recalled by: Manufacturer, by letter March 8, 1991. Firm-initiated
recall complete.
Distribution: New York.
Quantity: 10,068 bottles were distributed; firm estimates none
remains on the market.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Various OTC ophthalmic products:
(a) Liquid Sterile Ophthalmic, Phenylephrine HCl Ophthalmic
Solution, 1 fl oz., distributed by Rifer Labs;
(b) Tetrahydrozoline HCl Ophthalmic Solution Sterile,
1/2 fl oz., distributed by Rugby Labs;
(c) Tetraclear Tetrahydrozoline HCl Ophthalmic Solution,
1/2 fl oz, distributed by Schein Pharmaceutical;
(d) Sterile Artificial Tears, Demulcent (Lubricant)
Ophthalmic Solution, 1/2 fl oz, distributed by Rugby Labs;
(e) Akrinse, Eye Irrigating Solution, Sterile Solution
Isotonic Buffered, 1 fl oz, manufactured for Akorn, Inc;
(f) Ocumend brand Ocu-Tears Sterile Artificial Tears
Demulcant, 1/2 fl oz, disttributed by Ocumed, Inc.
Recall #D-296/301-1.
-5-
Code: All lots.
Manufacturer: Ocumed, Inc., Sarasota, Florida.
Recalled by: Ocumed, Inc., Roseland, New Jersey, by letter.
November 21, 1990. Firm-initiated recall ongoing.
Distribution: New York, Louisiana, Wisconsin, Puerto Rico.
Quantity: 203,233 bottles were distributed; firm estimates a
very small percentage of product remain on the market.
Reason: Lack of assurance of sterility.
----
Product: Sterile Bulk Ampicillin Sodium, USP, in 15 kg plastic
bags in fiberboard drums. Recall #D-302-1.
Code: Lot W901616.
Manufacturer: Wyeth-Ayerst Labs, West Chester, Pennsylvania.
Recalled by: Wyeth-Ayerst Labs, St. Davids, Pennsylvania, by
telephone March 8, 1991 followed by letter March 18,
1991. Firm-initiated recall ongoing.
Distribution: Indiana.
Quantity: 319.3 kg were distributed.
Reason: Lack of assurance of sterility.
----
Product: Carbamazepine Tablets, USP 200 mg, in 100, 500 and
1,000 tablet bottles, an Rx product used to control
and preclude epileptic episodes, under the Best,
Bioline, Glenlawn, Goldline, Harber, Major, Martec,
Moore, Parmed, Rugby labels. Recall #D-303-1.
Code: All lots.
Manufacturer: Pharmaceutical Basics, Inc., Denver, Colorado.
Recalled by: Manufacturer, by letter on or about March 15, 1991.
Firm-initiated recall ongoing. See also FDA talk
paper T91-13, March 14, 1991.
Distribution: Nationwide, Holland, Istanbul.
Quantity: 72,559,100 tablets were distributed.
Reason: Lack of assurance of bioequivalency and Abbreviated
New Drug Application discrepancies.
----
Product: Unasyn, Ampicillin Sodium/Sulbactam Sodium for
Reconstitution, sterile vials, an Rx anbibiotic.
Recall #D-304-1.
Code: Lot numbers V310A EXP 10/93, V320A EXP 10/93.
Manufacturer: Wyeth-Ayerst Labs, West Chester, Pennsylvania.
Recalled by: Wyeth-Ayerst Labs, St., St. Davids, Pennsylvania, by
telephone March 8, 1991 followed by letter March 18,
1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 24,790 packages of 10 were distributed.
Reason: Lack of assurance of sterility.
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-6-
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Recovered Plasma. Recall #B-133/136-1.
Code: Unit numbers: (a) 04K00397, 04M66160, 04S18164, 04X78211;
(b) 04K00397, 04K93117, 04M66160, 04S18164, 04X78211;
(c) 04K93117; (d) 04S18164.
Manufacturer: American Red Cross, Dedham, Massachusetts.
Recalled by: Manufacturer, by telephone December 6, 1989, February 12,
1990 and April 20, 1990 and by letters dated December 15,
1989, May 29, 1990 and April 27, 1990. Firm-initiated
recall ongoing.
Distribution: Massachusetts, California.
Quantity: (a) 4 units; (b) 5 units; (c) 1 unit (d) 1 unit.
Reason: Blood products collected from donors who 1) are
natives of areas considered high risk for the HIV-1
and HIV-2 viruses (South Africa and Cape Verde), 2) had
taken anti-malaria prophylaxis during travel in countries
endemic for malaria, or 3) had travelled in an area endemic
for malaria without prophylaxis within six months of
donation, were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Recovered Plasma. Recall #B-138/141-1.
Code: Unit numbers: (a) 33KG58153, 33KH38058, 33KM44888,
33KN56088; (b) 33KH38058, 33KN56088;
(c) 33KH38058, 33KM44888; (d) 33KG58153, 33KN56088.
Manufacturer: American Red Cross, Farmington, Connecticut.
Recalled by: Manufacturer, by telephone on or about October 4, 1990.
Firm-initiated recall complete.
Distribution: Connecticut, California, Massachusetts, Washington, D.C.
Quantity: (a) 4 units; (b) 2 units; (c) 2 units; (d) 2 units.
Reason: Blood products collected from donors who are natives
of areas considered high risk for the HIV-1 and HIV-2
viruses (Nigeria and South Africa), were distributed.
----
Product: (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Cryoprecipitated AHF; (e) Recovered Plasma.
Recall #B-174/178-1.
Code: Unit numbers: (a) 6H1023, 6H1047, 6R7182; (b) 3A6114,
6E5156, 6H1032, 6R7231, 7R2464, 8K3315, 8K4305, 8K5179,
8X3562, 8Y9076; (c) 3A6114, 6E5156, 6H1023, 6H1047, 6R7231,
7R2464, 8K3315, 8K4305, 8K5179, 8Y9076; (d) 3A6114, 6H1032,
6R7182, 8Y9076; (e) 3A6114, 6E5156, 6H1032, 6R7231,
7R2464, 8K3315, 8K4305, 8K5179, 8Y9076.
Manufacturer: Puget Sound Blood Center, Seattle, Washington.
Recalled by: Manufacturer, by letters of August 9, 1989 and
December 1, 1990. Firm-initiated recall complete.
Distribution: New York.
Quantity: (a) 3 units; (b) 10 units; (c) 10 units; (d) 4 units;
(e) 9 units.
-7-
Reason: Blood products which tested initially reactive or
repeatably reactive for the hepatitis B surface
antigen (HBsAg), were distributed.
----
Product: Platelets, Pheresis. Recall #B-179-1.
Code: Unit #462146.
Manufacturer: Belle Bonfils Memorial Blood Bank, Denver, Colorado.
Recalled by: Manufacturer, by telephone January 11, 1991.
Firm-initiated recall complete.
Distribution: Colorado.
Quantity: 1 unit.
Reason: Blood product labeled with incorrect expiration date
was distributed.
----
Product: Source Plasma. Recall #B-184-1.
Code: Unit numbers: B-05316-166, N-11581-142, E-05729-166.
Manufacturer: M.P.S. Inc., Opelousas, Louisiana.
Recalled by: Manufacturer, by telephone December 27, 1989
and March 2, 1990 and by letters December 27, 1989 and
March 5, 1990. Firm-initiated recall complete.
Distribution: California.
Quantity: 3 units.
Reason: Blood products which tested repeatably reactive to
human immunodeficiency virus type 1 (anti-HIV-1) or
hepatitis B surface antigen (HBsAg) were distributed.
----
Product: (a) Platelets; (b) Fresh Frozen Plasma;
(c) Red Blood Cells, Expired. Recall #B-185/187-1.
Code: Unit #13G23613.
Manufacturer: American Red Cross, Detroit, Michigan.
Recalled by: Manufacturer, by telephone October 19, 1990 followed
by letter December 14, 1990. Firm-initiated recall
ongoing.
Distribution: Michigan.
Quantity: 1 unit of each component.
Reason: Blood products which tested non-reactive for the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1), but collected from a donor who previously
tested repeatably reactive for anti-HIV-1, were distributed.
----
Class III -
Product: (a) Whole Blood; (b) Fresh Frozen Plasma.
Recall #B-180/181-1.
Code: Unit numbers: (a) 39027; (b) 436055.
Manufacturer: Belle Bonfils Memorial Blood Bank, Denver, Colorado.
Recalled by: Manufacturer, by telephone November 29-30, 1990.
Firm-initiated recall complete.
-8-
Distribution: Colorado.
Quantity 1 unit of each component.
Reason: Blood products labeled with incorrect expiration dates
were distributed.
----
Product: Fresh Frozen Plasma. Recall #B-182-1.
Code: Unit numbers 2260342, 2260345, 2260346, 2260347,
2268362, 2268364, 2268365, 2820932.
Manufacturer: Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
Recalled by: Manufacturer, by return of product September 26, 1990.
Firm-initiated recall complete.
Distribution: Indiana.
Quantity: 8 units.
Reason: Blood products with incorrect expiration dates were
distributed.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: Adult, Child and Infant Disposable Bag Easy Manual
Resuscitators used in the Listed Kits:
1. Order No. 412080, Child Bag Easy with Child Mask and
Peep;
2. Order No. 412081, Child Bag Easy with Peep;
3. Order No. 412082, Child Bag Easy with Child Mask;
4. Order No. 412083, Child Bag Easy;
5. Order No. 412084, Infant Bag Easy with Infant Mask
and Peep;
6. Order No. 412085, Infant Bag Easy with Peep;
7. Order No. 412086, Infant Bag Easy with Infant Mask;
8. Order No. 412087, Infant Bag Easy;
9. Order No. 412111, Infant Bag Easy with Infant and
Infant Neonatal Mask & Peep;
10. Order No. 412110, Infant Bag Easy with Infant and
Neonatal Mask;
11. Order No. 412038, Adult Bag Easy Drawstring with
Mask & Peep;
12. Order No. 412039, Adult Bag Easy Drawstring with
Mask;
13. Order No. 412040, Adult Bag Easy Drawstring with
Peep;
14. Order No. 412041, Adult Bag Easy Drawstring;
15. Order No. 412048, Adult Bag Easy Mini Pack with Mask
& Peep;
16. Order No. 412049, Adult Bag Easy Mini Pack with
Mask;
17. Order No. 412050, Adult Bag Easy Mini Pack with
Peep;
-9-
18. Order No. 412051, Adult Bag Easy Mini Pack.
Recall #Z-311/328-1.
Code: Firm's recall letter lists the following order numbers
that were shipped as single units to sales
representatives:
412042, 412043, 412045, 412046, 412119, 412120, 412105,
412106, 412107, 412108, 412109, 412112 and 412113. These
order numbers appear only on the shipping package.
Labeling on the device is identified as per order numbers
listed above. Lot numbers 179-200, A200-A323, B200-B224.
Manufacturer: Respironics Inc., Murrysville, Pennsylvania.
Recalled by: Manufacturer, by letters of December 19, 1990 and
January 29, 1991. Firm-initiated recall ongoing. See
also FDA press release P91-9, March 14, 1991.
Distribution: Nationwide and international.
Quantity: 162,660 units were distributed.
Reason: The bottom check valve may become either partially or
completely dislodged, resulting in inadequate volume
delivery or no volume delivery to the patient.
----
Class II -
Product: Getinge Steam and ETO Sterilizers with Powered
Horizontal Door Systems, Model PAC 50 and 50A.
Recall #Z-232/233-1.
Code: Series 4300, 4400, 4600, 4700, 4900.
Manufacturer: Getinge International, Inc., Lakewood, New Jersey.
Recalled by: Manufacturer, by letter March 31, 1989. Firm-initiated
field correction ongoing.
Distribution: Nationwide.
Quantity: 107 units were distributed.
Reason: The pneumatic horizontal powered sliding door may close
very quickly due to pressure build-up in the door
operating cylinder. This can result in operators and
maintenance personnel being severely crushed or burned
due to entrapment.
----
Product: Perfecta Rasp/Trial, a surgical instrument used to
prepare the femoral canal during hip replacement:
(a) Standard Version, Catalog #4708-XXXX;
(b) Reduced Flare version, Catalog #4703-XXXX.
Recall #Z-259/260-1.
Code: Lot numbers beginning with P87, P88, P89B, P89E, P89F.
Manufacturer: Orthomet, Inc., Minneapolis, Minnesota.
Recalled by: Manufacturer, by telephone November 1, 1989. Firm-
initiated recall complete.
Distribution: Nationwide, Belgium, Sweden, Switzerland.
Quantity: (a) 134 units; (b) 92 units were distributed.
Reason: The "post" or "trunnion" may break during rasp
extraction due to mechanical overload.
----
-10-
Product: (a) Ramses Extra Strength Condoms, Product #121, in boxes
of 12; (b) Ramses Extra strength Condoms, Product #122,
in boxes of 36. Recall #Z-348/349-1.
Code: Lot 09 07 93.
Manufacturer: Schmid Laboratories, Inc., Anderson, South Carolina.
Recalled by: Manufacturer, by visit October 16, 1990. Firm-initiated
recall complete.
Distribution: Nationwide.
Quantity: (a) 136 gross; (b) 169 gross were distributed.
Reason: Product contained an unacceptable level of holes
and ring tears.
----
Product: "IOPTEX" Ultraviolet Absorbing Posterior Chamber
Intraocular Lenses:
(a) Model U250F (Positioning Holes 0);
(b) Model U252F (Positioning Holes, 2).
Recall #Z-363/364-1.
Code: 432 lenses each with individual serial numbers are
involved.
Manufacturer: Ioptex Research, Inc., Irwindale, California.
Recalled by: Manufacturer, by letter November 8, 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: 65 lenses were distributed.
Reason: There is a possibility that the haptics (loop) may
have weak attachments (staves), and there is a
potential for the loop to be pulled out.
----
Product: "IOPTEX" Posterior Chamber Intraocular Lenses:
1. Model No. 301-01; 2. Model No. 301-03;
3. Model No. 301-09; 4. Model No. 304-01;
5. Model No. 304-07; 6. Model No. U250F;
7. Model No. U252F; 8. Model No. U260;
9. Model No. U265; 10. Model No. U270;
11. Model No. U272; 12. Model No. U360;
13. Model No. U360N; 14. Model No. U365;
15. Model No. U370; 16. Model No. U372;
17. Model No. U375; 18. Model No. UB360;
19. Model No. UB360S; 20. Model No. UB370;
21. Model No. UV302-45; 22. Model No. UP350;
23. Model No. UP360; 24. Model No. UP360N;
25. Model No. UP362; 26. Model No. UP383;
27. Model No. UP675; 28. Model No. UPB260S;
29. Model No. UPB350S; 30. Model No. UPB360;
31. Model No. UPB370; 32. Model No. UPB380;
34. Model No. UPB385; 35. Model No. UV301-01;
36. Model No. UV301-02; 37. Model No. UV301-03;
38. Model No. UV301-04; 39. Model No. UV301-09;
40. Model No. UV302-01; 41. Model No. UV302-02;
42. Model No. UV302-08; 43. Model No. UVC324-57;
-11-
44. Model No. UV304-00; 45. Model No. UV304-01;
46. Model No. UV304-07; 47. Model No. UV304-21;
48. Model No. UV307-04; 49. Model No. UV308-01;
50. Model No. UV308-03; 51. Model No. UV308-07;
52. Model No. UV311-00; 53. Model No. UV311-58;
54. Model No. UV321-57; 55. Model No. UV321-59;
56. Model No. UV322-47; 57. Model No. UV324-57;
58. Model No. UV324-59; 59. Model No. UV350-07;
60. Model No. UVB308-01; 61. Model No. UVB350-03;
62. Model No. UVB370-07; 63. Model No. UVC304-09;
64. Model No. UVCH304-01; 65. Model No. UVH301-01;
66. Model No. UVH302-01; 67. Model No. UVH304-01;
68. Model No. UVH309-01; 69. Model No. UVH324-51;
70. Model No. UVHN304-03; 71. Model No. UVL301-03;
72. Model No. UVLC304-01; 73. Model No. UVLH304-01;
74. Model No. UVN301-12; 75. Model No. UVN304-07.
Recall #Z-365/438-1.
Code: All lenses from sterilization lot 0423 through 0468,
that have been distributed domestically and have not been
implanted.
Manufacturer: Ioptex Research, Inc., Irwindale, California.
Recalled by: Manufacturer, by letter December 7, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: Approximately 125,000 lenses were distributed.
Reason: The company failed to file and obtain approval of a
supplement to their Premarket Approval application (PMA)
for changing manufacturing facilities from Azusa to
Irwindale, California.
----
Class III -
NONE
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Neomycin Uterine Bolus, 50 bolus jars, 500-mg, Neomycin
Sulfate, OTC, oral and or intrauterine administration,
under the following labels: Uterine Bolus,
Lextron, Inc., Greeley, CO; Uterine Bolus, Premier
Farmtech, Kansas City, MO; Neomycin Bolus, IBA, Inc.
Animal Health Division, Millburg, MA; Uterine Bolus,
Animal Health Associates, Kansas City, MO; and Uterine
Bolus, Durvet, Inc., Blue Springs, MO.
Recall #V-057-1.
Code: All lot numbers.
Manufacturer: Interstate Foods Marketing Ltd., Richmond, Virginia.
Recalled by: Manufacturer, by letters sent October 4, 1990
through December 19, 1990. Firm-initiated recall ongoing.
-12-
Distribution: Nationwide.
Quantity: 3,660/50-bolus jars were distributed.
Reason: Current good manufacturing practice deviations.
----
Class III -
Product (a) Veterinary Surfactant, 16 fl oz and 1 gallon jugs, water
miscible solution of Dactyl Sodium Sulfosuccinate, liquid,
OTC, rectal and/or oral administration, for use in horses,
cats and dogs, distributed by Vedco, Inc., St. Joseph, MO;
(b) Magnesium Oxide Bolus, 50-bolus jars, 276 gr
magnesium oxide per bolus, OTC, oral administration, for
use in cattle, under the following labels:
Magnalax Boluses, Vedco, Inc., St. Joseph, MO; Rumen
Boluses, Durvet, Inc., Blue Springs, MO; Rumalax Boluses,
Animal Health Associates, Kansas City, MO;
(c) Disposable Enema, 12 ml Syringe, 250 mg Dioctyl Sodium
Sulfonsuccinate in 12 ml of glycerin, OTC, Rectal
administration, under the following labels:
Techamerica En-Enze, Fermenta Animal Health Co.,
Kansas City, MO; and Disposable Enema, Vedco, Inc., St.
Joseph, MO;
(d) Neomycin Sulfate Wound Powder, 1 oz bottle, 5 mg
Neomycin Sulfate, OTC, topical administration, for use in
horses, dogs, and cats, marketed as Ne-Sul Powder,
Durvet, Inc., Blue Springs, MO;
(e) Cough-Dex Compressed Tablets, in 500 tablet bottles,
Dextromethorphan Hydrobromide 10 mg and Chlorpheniramine
Maleate 4 mg, Rx, oral administration, for use in dogs and
cats, labeled and distributed by Vedco, Inc., St. Joseph,
MO;
(f) Antidiarrheal Liquid, 4 oz and 1 gallon containers,
120 mg Neomycin Sulfate, 1.0 mg Methscopalamine Bromide,
90 gr Kaolin and 9 gr Pectin, OTC, oral administration,
for use in dogs and cats, under the following labels:
Neo-Meth K/P, Vedco, Inc., St. Joseph, MO; K-Pec Plus
NMPK, Burns Veterinary Supply, Rockville Center, NY; and
NMKP, Victor Medical Co., Irvine, CA
(g) 52% Piperazine Wormer, 1-lb container, powder, OTC,
oral administration, for use in poultry, swine, dogs,
cats and horses, labeled for Miller Chemical Co., Omaha,
NE and Farmland Industries Inc., Kansas City, MO;
(h) Kaolin Pectin, 1 qt and 1 gallon containers, 90 gr
Kaolin and 2 gr Pectin, liquid, OTC, oral administration
for use in horses, cattle, dogs and cats, under the
Durvet, Inc., Blue Springs, MO., and Vedco, Inc., St.
Joseph, MO. labels;
(i) Dune High Calories Liquid and Diet Supplement, 2 fl
oz and 16 fl oz containers, liquid, OTC, oral
administration, under the following labels:
Durvet, Inc., Blue Springs, MO; Kaeco Group, Inc.,
-13-
Savannah, MO; Lightning Products, Kansas City, MO; and
Vedco, Inc., St. Joseph, MO.
(j) Organic Iodide, in 1 lb and 25 gallon containers, 20
gr/oz and 40 gr/oz, Ethylenediamine Dihydroiodide,
powder, oral administration, under the following labels:
E.D.D.I. 20 gr Organic Iodine and Organic Iodine-40,
Vedco, Inc., St. Joseph, MO; and Organic Iodide 20 and
Organic Iodide 40, Durvet, Inc., Blue Springs, MO.
Recall #V-058/067-1.
Codes: (a-c) All lots; (d) 0172; (e) 0150; (f-i) All lots
(j) 0026, 0026A through 0026F, 0027A through 0027C, 0029A
through 0029C.
Manufacturer: Interstate Foods Marketing Ltd., Richmond, Virginia.
Recalled by: Manufacturer, by letters October 4, 1990 through
December 19, 1990, except product (i) Dyne, whose
letter was dated December 18, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide.
Quantity: Approximately (a) 868/1 gallon and 432/16 fluid ounce
containers; (b) 6,660/50 bolus jars; (c) 17,280 syringes;
(d) 2,880 bottles; (e) 984 bottles; (f) 8,280/4 oz
and 1,924/1 gallon containers; (g) 1,742/1 lb bags and
1/110 lb drum; (h) 1,176 /1 quart and 4,845/1 gallon
containers; (i) 1,152/2 fl oz and 4,476/16 fl oz
bottles; (j) 1,850/1 lb and 60/25 lb bags.
Reason: Total lack of CGMP'S and firm manufacturing numerous
unapproved new animal drugs. Organic iodide products
being recalled due to firm substituting potassium iodide
as active ingredient in place of EDDI as specified.
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Medical Device Safety Alerts:
Product: Bjork-Shiley 60 Convexo-Concave Heart Valve 21, 23, 25,
27, 29, 31, 33 mm sizes. Safety Alert #M-006/012-1.
Code: All lots -- All serial numbers.
Manufacturer: Shiley, Inc., Irvine, California.
Alerted by: Manufacturer by implementing a patient notification
program November 30, 1990. See also FDA press release
P90-60, December 11, 1990.
Distribution: Nationwide and Canada.
Quantity: All large valves (29-33mm) were withdrawn from commerce
on October 14, 1985. All small valves (21-27mm) were
withdrawn on November 24, 1986. Shiley estimates that
all have been implanted or destroyed and none remain in
commerce.
Reason: Possible strut fracture.
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Seizure Actions Filed:
Product: Olives (91-576-677).
-14-
Charge: Adulterated - Product is contaminated with yeast.
Firm: Bob Gordon and Associates, Ltd., Chicago, Illinois.
Filed: March 7, 1991 - U.S. District Court for the Northern
District of Chicago, Eastern Division; Civil #91C1400,
FDC #66056.
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Product: Comingled lot of Diced Jalapeno Peppers (91-610-411).
Charge: Adulterated - Product contaminated with mold
and yeast.
Firm: LaPreferida, Chicago, Illinois.
Filed: March 20, 1991 - U.S. District Court for the Northern
District of Illinois, Eastern Division;
Civil #91C1716, FDC #66063.