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
06/09/1993
Recalls and Field Corrections: Foods -- Class I -- CORRECTED COPY --
06/09/1993
CORRECTED COPY
June 9, 1993
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
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PRODUCT Chunk Light Tuna and Solid White Tuna, in 6-1/8 ounce metal
cans, in shrink wrapped packages of 4, 6, or 8 cans.
Recall #F-346-3.
CODE All lots shrink wrapped by Laney and Duke Company prior to
February 15, 1993.
MANUFACTURER Laney and Duke Company, Jacksonville, Florida (repacker).
RECALLED BY Van Camp Seafood Company, Inc., San Diego, California, by
salesman visit on or about March 29, 1993. Firm-initiated
field correction complete.
DISTRIBUTION Florida, New York.
QUANTITY Undetermined.
REASON The possibility for some cans to be punctured or cut during
repackaging which provided the potential to be contaminated
with Clostridium botulinum bacteria or spores with
subsequent production of neurotoxin.
________________
PRODUCT Fresh crabmeat in 16 ounce plastic containers with plastic
snap-on lids: (a) Jumbo Lump Crabmeat; (b) Backfin
Crabmeat; (c) Special Crabmeat; (d) Claw Special Crabmeat.
Recall #F-442/445-3.
CODE All crabmeat processed during the period of 3/9-17/93.
MANUFACTURER Craven Crab Company, New Bern, North Carolina.
RECALLED BY Manufacturer, by telephone followed by letter March 26,
1993. Firm-initiated recall complete.
DISTRIBUTION North Carolina, Maryland, Pennsylvania, New York.
QUANTITY (a) 857 pounds; (b) 2,212 pounds; (c) 483 pounds; (d) 58
pounds were distributed.
REASON Products are contaminated with Listeria monocytogenes.
________________
PRODUCT Dried Apricots, in 2.5 ounce cello bags. Recall #F-446-3.
CODE None.
MANUFACTURER California Products of New Jersey, East Brunswick, New
Jersey.
RECALLED BY Manufacturer, by visit on or about December 17, 1992.
Firm-initiated field correction (relabeling) complete.
DISTRIBUTION New York.
QUANTITY Approximately 450 bags were distributed. All products were
relabeled in December 1992.
REASON Products contain undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
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PRODUCT (a) Borden artificially flavored drinks having the
following flavors and bottle sizes:
1. Orange Drink, gallon, 10 ounce and 1/2 pint
2. Fruit Punch, gallon, 10 ounce
3. Grape Drink, gallon, 10 ounce
4. Lemon Drink, gallon, 10 ounce
5. Papaya Drink, gallon, 10 ounce
(b) Borden Cottage Cheeses having the following varieties
and container sizes:
1. Large Curd, 25 pound, 5 pound, 24 ounce, 16 ounce
2. Small Curd, 25 pound, 5 pound, 24 ounce, 16 ounce, 8
ounce
3. Lowfat, 5 pound, 24 ounce, 16 ounce
4. Lowfat with Pineapple Added, 16 ounce
5. Lowfat with Chive Added, 16 ounce
(c) Four types of Cottage cheese put up under two private
labels for Pritikin, Inc:
1. Becker Large Curd, 5 pound, 24 ounce, 12 ounce
2. Becker Small Curd, 5 pound, 24 ounce, 12 ounce
3. Becker Low Fat, 24 ounce, 12 ounce
4. Mid-City Large Curd, 5 pound
5. Becker Dry Curd, 30 pound. Recall #F-347/360-3.
CODE Drink products in gallon containers -- All product with a
lot number of 187 and below.
Small Sizes (10 ounce and 1/2 pint) of drinks -- All
product with a lot number of 132 and below.
Cottage products -- All product with pull-dates of Apr 4
through Apr 27.
MANUFACTURER Borden, Inc., West Allis, Wisconsin.
RECALLED BY Manufacturer, by telephone April 8 and 9, 1993, followed by
letters of April 9 and 15, 1993. Firm-initiated recall
complete.
DISTRIBUTION Wisconsin, Illinois, Indiana.
QUANTITY Approximately 21,000 gallons of the fruit drinks and 72,000
pounds of cottage cheese were distributed.
REASON Products were manufactured using water that may be
contaminated with cryptosporidium.
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PRODUCT Various party foods:
(a) Herring Party Bites in Wine Sauce, all sizes (16 oz.,
24 oz, 40 oz, 60 oz, 8 pound pail, 15 pound pail, 30 pound
pail, and 45 pound pail);
(b) Herring Party Bites in Sour Cream, all sizes (16 oz, 24
oz, 40 oz, 60 oz, 8 pound pail, 15 pound pail, 30 pound
pail, and 45 pound pail);
(c) Herring Rollmops in Wine Sauce, all sizes (24 oz 40 oz,
60 oz);
(d) Hard-Boiled Pickled Eggs Packed in Vinegar Brine, all
sizes (16 oz jars and boxes holding 20 individual 35-cent
packets of the eggs). Recall #F-362/365-3.
CODE All products shipped to consignees from 3/15/93 to 4/16/93.
MANUFACTURER Bay View Packing Company, Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by telephone April 16, 1993, followed by
letter April 19, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Wisconsin, Minnesota.
QUANTITY Approximately 5,000 pounds were distributed.
REASON Products were manufactured using water that may be
contaminated with cryptosporidum.
________________
PRODUCT The following prepared salad products were recalled (where
not otherwise stated, below, the brand name of the products
is Garden-fresh):
1. American Potato Salad
2. Antipasto Salad
3. Antipasto Supreme
4. Broccoli Cheese Salad
5. Broccoli Cheese Base
6. Broken Glass Gelatin
7. Carmel Dip
8. Carrot Raisin Salad
9. Cheddar Pasta Salad
10. Cheese Tortellini
11. Cherry Ribbon Gelatin
12. Chicken Salad
13. Chopped Cole Slaw
14. Claremont Salad
15. Combo Bean Salad
16. Country Style Potato Salad
17. Creamy Pasta Salad
18. Creeme Potato Salad
19. Diced Strawberry Gelatin
20. Egg Salad
21. Egg Salad Spread
22. French Potato Salad
23. Fruit Melody
24. Gourmet Potato Salad Base
25. Gourmet Seafood and Shrimp
26. Greek Olive Salad
27. Italian Pasta Base
28. Italian Spaghetti Salad
29. Kidney Bean Salad
30. King Krab Health Salad
31. King Krab Seafood Salad
32. Lemon Walnut Dessert
33. Lime Leprechaun Gelatin
34. Lime Pear Gelatin
35. Lime Whip Gelatin
36. Macaroni Salad
37. Mandarin Orange Gelatin
38. Manny's Mild Salsa
39. Mild Cole Slaw
40. Fresh Mushroom Supreme
41. Mustard Potato Salad
42. Old Fashion Potato Salad
43. Old Fashion Sour Cream Cuke
44. Olive Supreme
45. Orange Whip Gelatin
46. PCI Macaroni Salad
47. PCI Cole Slaw
48. PCI Potato Salad
49. Pasta by the Season
50. Pasta Salad
51. Pickled Beets & Onions
52. Pineapple Walnut Dessert
53. Premium Cole Slaw
54. Rainbow Gelatin
55. Red Jacket Potato Salad
56. Homestyle Potato Salad
57. Fresh Salsa, Mild
58. Seafood Fettuccine
59. Seafood Royale
60. Seafood Salad
61. Sentry American Potato Salad
62. Shredded Cole Slaw
63. Shrimp Dip
64. Shrimp Salad
65. Shrimp Base
66. Sour Cream Cucumber
67. Strawberry Fruit Gelatin
68. Strawberry Whip Gelatin
69. Sweet and Sour Cole Slaw
70. Tortellini Marinara
71. Tuna Pasta Salad
72. Tuna Salad
73. Tuna Base
74. Tuna Spread
75. Vegi Pasta
76. Western Salad. Recall F-366/441-3.
Also fresh-cut produce dated 4/07/93, 4/08/93 and 4/09/93
was recalled.
CODE Lots (pull dates) affected:
1. 4-20, 4-21, 4-26, 4-27, 4-29, 5-3, 5-4, 5-5, 5-7,
5-11, 5-13
2. 4-23, 5-7
3. 4-23, 4-30
4. 4-16, 4-22, 4-24, 4-30, 5-1, 5-6
5. 4-16, 4-19, 4-23, 4-24, 4-26, 4-30, 5-1, 5-6
6. 5-22, 5-24, 7-1, 7-2, 7-6
7. 5-6
8. 4-19, 4-29, 5-4
9. 4-23, 4-31, 5-7
10. 4-16, 4-17, 4-18, 4-22, 4-31
11. 6-16, 7-6
12. 4-18, 4-23, 4-25, 4-30, 5-1, 5-6, 5-8
13. 4-27
14. 4-21
15. 4-26, 5-4, 5-11
16. 5-5
17. 4-19
18. 4-20, 4-27, 5-6, 5-7, 5-13
19. 6-23, 6-25, 6-30, 6-31, 7-2, 7-6, 7-7
20. 4-23, 5-6
21. 4-30, 5-5
22. 4-21, 4-28, 5-5, 5-13
23. 4-20
24. 4-31, 5-7
25. 4-16, 4-25, 5-6
26. 4-16, 4-30, 5-6
27. 5-1
28. 4-24, 5-6
29. 4-20, 4-26, 4-28, 5-5, 5-11
30. 4-16, 4-17, 5-1
31. 4-17, 5-1
32. 4-1, 4-30
33. 7-6
34. 7-16, 7-31, 8-5
35. 6-15, 6-23, 7-6
36. 4-22, 4-26, 4-27, 4-28, 5-6, 5-7, 5-5, 5-12
37. 7-1, 8-7
38. 5-13, 5-15, 5-28
39. 4-20, 5-7
40. 4-23, 5-1
41. 4-21, 4-26, 4-28, 4-29, 5-3, 5-5, 5-6, 5-7, 5-11, 5-13
42. 4-26
43. 4-22, 5-6, 5-13
44. 4-19, 4-24, 5-6
45. 6-16, 6-29
46. 4-27, 5-3, 5-11
47. 4-21, 4-27, 5-3, 5-11
48. 4-21, 5-11
49. 4-20, 4-23, 4-30, 5-6
50. 4-22, 5-7, 5-13
51. 4-28, 5-12
52. 4-24, 5-6, 5-7
53. 4-20, 4-21, 4-23, 4-29 5-5, 5-12
54. 5-15, 5-17, 5-18, 5-19, 5-22, 5-24, 5-25, 5-30,
6-2, 6-5, 6-7
55. 4-17, 4-23, 4-31, 5-7
56. 4-22, 4-26, 5-6, 5-13
57. 4-17, 4-30, 4-29, 5-7
58. 4-24, 5-1, 5-7
59. 4-19, 4-25, 5-1, 5-8
60. 4-16, 4-23, 5-5
61. 4-20, 4-22, 4-23, 4-27, 4-28, 5-5, 5-7, 5-12, 5-13
62. 4-19, 4-20, 4-21, 4-22, 4-23, 4-27, 4-28, 5-3,
5-4, 5-5, 5-6, 5-7, 5-11, 5-12
63. 5-18, 5-23, 6-7
64. 4-19, 4-25
65. 4-22, 4-28, 5-4, 5-5, 5-11, 5-13
66. 4-29
67. 7-30
68. 6-16, 6-26, 7-7
69. 4-19, 4-20, 4-22
70. 4-23
71. 4-23
72. 4-16, 4-26, 5-5
73. 4-20, 4-26, 5-12
74. 4-23
75. 4-24, 5-6
76. 4-20, 4-26, 5-5, 5-12
MANUFACTURER Garden-Fresh Foods, Inc., Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by letter dated April 15, 1993. Firm-
initiated recall complete.
DISTRIBUTION Wisconsin, Illinois.
QUANTITY Approximately 60,000 pounds were distributed.
REASON Products were manufactured with city water that may have
been contaminated with cryptosporidum.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
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PRODUCT Doxepin Hydrochloride Capsules, USP, (a) 100 mg, in bottles
of 100; (b) 150 mg, in bottles of 50, a Rx anti-depressant.
Recall #D-272/273-3.
CODE Control numbers: 346-154 EXP 11/94; 346-155 EXP 12/94.
MANUFACTURER Lederle Arzneimittel Cyanamid GmbH, West Germany.
RECALLED BY Lederle Laboratories, Division of American Cyanamid
Company, Pearl River, New York, by letter May 21, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Arkansas, Colorado, Connecticut, Florida,
Louisiana, Maine, Pennsylvania, Kentucky, New Jersey,
Virginia, West Virginia, South Carolina, Tennessee, Texas.
QUANTITY (a) 1,201 bottles; (b) 1,553 bottles were distributed.
REASON Products do not meet dissolution specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
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PRODUCT Multi-Symptom Non-Aspirin Cold Formula Tablets, 24 tablets
per blister package, an OTC product. Recall #D-270-3.
CODE Lot #104151D EXP 5/93.
MANUFACTURER Able Laboratories, Division of A.L. Laboratories,
Plainfield, New Jersey.
RECALLED BY Manufacturer, by letter January 13, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,486 units were distributed.
REASON Firm extended expiration date without supporting stability
data.
_______________
PRODUCT Chloromycetin Cream, 1% (Chloramphenicol Cream, USP), in 1
ounce tubes, Rx topical used for the treatment of surface
skin infections. Recall #D-271-3.
CODE Lot #00172B EXP 7/93.
MANUFACTURER Parke Davis Canada, Inc., Ontario, Canada.
RECALLED BY Warner-Lambert Company, Parke-Davis Division, Morris
Plains, New Jersey, by letter dated April 26, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6,216 tubes were distributed; firm estimates 2,000 tubes
remain on the market.
REASON Product does not meet specifications for the propylparaben
ingredient.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
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PRODUCT Aveco Brand Amforol Veterinary Oral Suspension, in 16 ounce
plastic bottles, a Rx product used for the treatment of
bacterial enteritis in dogs, and the symptomatic relief of
associated diarrhea. Recall #V-028-3.
CODE Lot numbers: 404106, 404107, 404108.
MANUFACTURER Fort Dodge Laboratories, Inc., Fort Dodge, Iowa.
RECALLED BY Aveco Company, Inc., Fort Dodge, Iowa, by letter dated May
21, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,370 bottles of lot 404106, 3,495 bottles of lot 404107,
1,495 bottles of lot 404108 were distributed.
REASON Lot 404106 - Subpotent in Attapulgite and Bismuth
Subcarbonate.
Lot 404107 - Superpotent in Bismuth Subcarbonate.
Lot 404108 - Insufficient stability data to justify
expiration date.
RECALLS AND FIELD CORRECTION: VETERINARY PRODUCTS -- CLASS III
===========
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PRODUCT Two tons 42% Protein Hog G Feed. Recall #V-027-3.
CODE None.
MANUFACTURER Agway, Inc., Winfield, Pennsylvania.
RECALLED BY Manufacturer. All feed was returned to the Agway Feed Mill
on April 15, 1993. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimates none remains on the market.
REASON 1/2 ton pig starter containing Pyrantel Tartrate and
Carbadox was inadvertently mixed with a two ton shipment of
non-medicated 42% hog concentrate.
END OF ENFORCEMENT REPORT FOR JUNE 9, 1993. BLANK PAGES MAY FOLLOW.
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