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.
November 24, 1999 99-47
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________
PRODUCT
Blue Ribbon brand a) Whitefish Salad in 8 ounce plastic tubs; b)
Baked Salmon Salad in 8 ounce plastic tubs.
Recall #F-054/055-0.
CODE
Both products are coded SELL BY 1008 and have a batch code of 236
on a separate label on the bottom of the container.
MANUFACTURER
Blue Ribbon Smoked Fish Company, Brooklyn, New York.
RECALLED BY
Manufacturer, by telephone, letter and fax on September 17, 1999.
Completed recall resulted from sample analysis and follow-up by
the New York State Department of Agriculture and Markets.
DISTRIBUTION
New York and New Jersey.
QUANTITY
A total of 300 8-ounce packages of White Fish Salad and 111 8-ounce
packages of Baked Salmon Salad were distributed; Firm
estimates none remains on the market.
REASON
Products were contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
________
PRODUCT
a) Ana-KitÆ Anaphylaxis Emergency Treatment Kit-
consisting of 1 syringe (1.0 mL) containing two single doses
(0.3 mL) of Epinephrine Injection USP, (1:1000), 4 tablets
(Chlorpheniramine Maleate) of antihistamine, and 2 sterile
isopropyl alcohol (70%) swabs, labeled in part "Pkgd. and Dist.
By: Bayer Corporation Pharmaceutical Division Spokane, WA 99207
** Epinephrine Mfg by: Wyeth-Ayerst Laboratories Philadelphia, PA
19101***", for treatment of severe anaphylactic or anaphylactoid
reactions and severe asthma. Sold as individual kits or 6-packs.
NDC 0026-9988-01 and 0026-9988-06;
b) Ana-GuardÆ Epinephrine Injection USP (1:1000)-
consisting of 1 syringe (1.0 mL) containing two single doses
(0.3 mL) of Epinephrine Injection USP, (1:1000). labeled in part
"ANA-GUARD EPINEPHRINE INJECTION, USP (1:1000) ** Pkgd. and Dist.
By: Bayer Corporation Pharmaceutical Division Spokane, WA 99207
USA Epinephrine Mfg. By: Wyeth-Ayerst Laboratories Philadelphia,
PA 19101***. NDC 0026-9984-01 and 0026-9984-06;
c) Epinephrine Injection, USP (1:1,000) Syringe - a refill item
for the above two products sold as 500 syringes/box under NDC#
0026-9982-01 each containing two single doses (0.3 mL) of
Epinephrine Injection USP, (1:1000).
Recall #D-059/061-0.
CODE
Ana-Kit:
AK344 EXP Date 8-99 AK345 EXP Date 8-99
AK346 EXP Date 9-99 AK347 EXP Date 11-99
AK348 EXP Date 1-2000 AK349 EXP Date 5-2000
AK350 EXP Date 9-99 AK351 EXP Date 11-99
AK352 EXP Date 9-99 AK353 EXP Date 5-2000
AK354 EXP Date 6-2000 AK355 EXP Date 6-2000
AK356 EXP Date 7-2000 AK357 EXP Date 9-99
AK358 EXP Date 1-2000 AK359 EXP Date 8-2000
AK360 EXP Date 9-99 AK361 EXP Date 9-99
AK362 EXP Date 11-99 AK363 EXP Date 1-2000
AK366 EXP Date 7-2000
Ana-Guard:
G00196 thru G00203 (inclusive) EXP Date September 1999
G00204 & G00205 EXP Date November 1999
G00206, G00207, G00208 EXP Date January 2000
G00209 EXP Date May 2000
G00210 EXP Date June 2000
G00211, G00212, G00213 EXP Date July 2000
G00214 through G00220 (inclusive), G00222, G00223
EXP Date August 2000
Epinephrine Injection Refills:
S315 EXP Date Aug 1999
S316 through S320 (inclusive) EXP Date Sept 1999
S321, S322, S323 EXP Date Nov. 1999
S324 through S327 (inclusive) EXP Date Jan 2000
S328 through S333 (inclusive) EXP Date May 2000
S334, S335, S336 EXP Date July 2000
S337 through S340 (inclusive) EXP Date Aug 2000.
MANUFACTURERS
Epinephrine: Wyeth-Ayerst Laboratories, Philadelphia,
Pennsylvania (responsible firm);
Ana-Kit and Ana-Guard: Hollister-Stier Laboratories LLC, Spokane,
Washington (formerly a Bayer Corporation Pharmaceutical Division
Company).
RECALLED BY
Hollister-Stier Laboratories LLC., Spokane, Washington, by
letters dated August 24, 25,and 30, 1999, and by fax on August
24, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Ana-Kit: 456,036 kits were distributed
Ana-Guard: 55,238 kits were distributed
Refills: 62,027 distributed
REASON
Subpotency of the Epinephrine.
________
PRODUCT
DERM/BURO INSECT STING KIT, Rx - consisting of 1 syringe (1.0 mL)
containing two single doses (0.3 mL) of Epinephrine Injection
USP, (1:1000), 4 chewable tablets (Chlorpheniramine Maleate) of
antihistamine, 2 sterile isopropyl alcohol (70%) swabs and one
tourniquet. Per label: "Pkgd. and Dist. by: Derm/Buro Inc.,
Deerfield, IL 60015". Recall #D-062-0.
CODE
Derm/Buro KIT Lot #/EXP Date Epinephrine Lot #/EXP Date
(in Kit)
#0397, 11/99 2971529, 11/99
#0497, 11/99 2971529, 11/99
#0497, 02/00 2971534, 02/00
#0597, 02/00 2971534, 02/00
#8141, 02/00 2971534, 02/00
#8141, 05/00 2971538, 05/00
#8139, 05/00 2971538, 05/00
#11464, 05/00 2971538, 05/00
#11464, 05/00 2983265, 07/00
#13239, 05/00 2983265, 07/00.
MANUFACTURER
Wyeth Ayerst Laboratories, West Chester, Pennsylvania (maker of
Epinephrine/responsible firm).
RECALLED BY
Derm/Buro, Inc., Plainview, New York (distributor of sting kit),
by letter dated August 23, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
U.S. government military installations nationwide.
QUANTITY
59,964 kits were distributed.
REASON
Subpotency of the Epinephrine.
________
PRODUCT
Epinephrine Injection, USP, 1:1000, Rx, in 1 mg/1 mL Tubex Æ
syringes, (25 gauge 5/8 inch needle) units of 10, used to treat
respiratory distress in bronchial asthma or during severe, acute
asthma attacks, reversible bronchospasms, severe acute
anaphylactic reactions, cardiac arrest - to restore cardiac
rhythm, and hypersensitivity reactions to drugs, sera, insect
stings or other allergens. (NDC# 0008-0263-01) and 50 (NDC# 0008-
0263-02). Recall #D-063-0.
CODE
NDC 0008-0263-01 - Lots: 2971529 EXP 11/99, 2971530 EXP 9/99,
2971534 EXP 2/00, 2971535 EXP 3/00, 2971536 EXP 4/00, 2971538 EXP
5/00, EXP 2983265 EXP 7/00.
NDC 0008-0263-02 - Lots: 2971525 EXP 8/99, 2971526 EXP 9/99,
2971531 EXP 11/99, 2971533 EXP 1/00, 2971537 EXP 5/00, 2983255
EXP 6/00, 2983256 EXP 7/00, and 2983257 EXP 8/00.
MANUFACTURER
Wyeth Ayerst Laboratories, West Chester, Pennsylvania.
RECALLED BY
Wyeth Ayerst Research, inc., Radnor, Pennsylvania, by letter
dated August 19, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Sweden.
QUANTITY
516,610 tubex/syringes of NDC 0008-0263-01 and 651,600
tubex/syringes of NDC 0008-0263-02 were distributed.
REASON
Subpotency.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma;
d) Recovered Plasma. Recall #B-034/037-0.
CODE
Unit Numbers: a) 04H71124, 04J96323; b) 04H71124, 04J96323;
c) 04H71124; d) 04J96323.
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by letter dated June 11 or 21, 1999, or fax on June
15, 1999. Firm-initiated recall complete.
DISTRIBUTION
New York, Maine, Massachusetts, California.
QUANTITY
a) 2 units; b) 2 units; c) 1 unit; d) 1 unit.
REASON
Blood products were collected from an unsuitable donor.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-117/119-0.
CODE
Unit Numbers: a) 22LQ61516, 22GZ73653; b) 22LQ61516;
c) 22LQ61516.
MANUFACTURER
American National Red Cross, Philadelphia, Pennsylvania.
RECALLED BY
Manufacturer, by letters dated April 15, 1998 or December 11,
1998, and by telephone on April 10, 1998, or December 1, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were not quarantined after receiving information
concerning a post donation illness.
________
PRODUCT
a) Red Blood Cells; b) Cryoprecipitated AHF.
Recall #B-126/127-0.
CODE
Unit #30GH25982.
MANUFACTURER
American National Red Cross, Ashley, Pennsylvania.
RECALLED BY
Manufacturer, by letter dated March 13, 1998, and by telephone on
March 6, 1998. Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania and Massachusetts.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor diagnosed with Mycosis
Fungoides.
________
PRODUCT
Red Blood Cells, Leukoreduced. Recall #B-129-0.
CODE
Unit #03KQ06498.
MANUFACTURER
American Red Cross Blood Services, Savannah, Georgia.
RECALLED BY
Manufacturer, by telephone on March 30, 1999, and by letter dated
April 15, 1999. Firm-initiated recall complete.
DISTRIBUTION
Georgia.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had been deferred
for a history of antibiotic therapy.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Plamsa, Cryoreduced;
d) Cryoprecipitated AHF; e) Recovered Plasma.
Recall #B-132/136-0.
CODE
Contact FDA, Center for Biologics Evaluation and Research, Office
of Compliance (301) 827-6220 for individual unit numbers
recalled.
MANUFACTURER
American Red Cross Blood Services, Rochester, New York.
RECALLED BY
Manufacturer, by letters dated August 14 or 17, 1998, September
25, 1998, and in November 1998. Firm-initiated recall complete.
DISTRIBUTION
New York, Pennsylvania, Florida.
QUANTITY
a) 39 units; b) 23 unit; c) 1 unit; d) 1 unit; e) 32 units were
distributed.
REASON
Blood products that were not tested for syphilis and unexpected
antibodies.
________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall #B-137-0.
CODE
Unit #19235-6429.
MANUFACTURER
United Blood Services, Reno, Nevada.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated June
23, 1998. Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was mislabeled as CMV antibody negative.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-139/141-0.
CODE
Unit #19021-5133.
MANUFACTURER
United Blood Services, Reno, Nevada.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated
December 17, 1998, or by fax on December 18, 1998. Firm-
initiated recall complete.
DISTRIBUTION
Illinois, Nevada, Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who had previously
been deferred after requesting that a donation be identified for
confidential self exclusion.
________
PRODUCT
Red Blood Cells. Recall #B-142-0.
CODE
Unit Numbers: 0467203, 0467181, 0123666, 0123842.
MANUFACTURER
Euroblood Center, Amsterdam, Netherlands.
RECALLED BY
New York Blood Services (Center West), New York, New York, by
letter dated September 14, 1999. Firm-initiated recall complete.
DISTRIBUTION
New Jersey and New York.
QUANTITY
4 units were distributed.
REASON
Blood products were collected from donors who previously
tested reactive for syphilis within one year of donation.
________
PRODUCT
Platelets. Recall #B-144-0.
CODE
Unit #22KR45359.
MANUFACTURER
American National Red Cross, Philadelphia, Pennsylvania.
RECALLED BY
Manufacturer, by letter dated March 24, 1999. Firm-initiated
recall complete.
DISTRIBUTION
New Jersey.
QUANTITY
1 unit was distributed.
REASON
Blood product corresponded to a unit of clotted red blood cells.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________
PRODUCT
a) Whole Blood; b) Red Blood Cells; c) Red Blood cells,
Leukocytes Reduced; d) Fresh Frozen Plasma; e) Platelets; f)
Platelets, Pheresis; g) Recovered Plasma; h) Recovered Plasma for
further Manufacturing of Non-Injectable Products; i) Red Blood
Cells for Further Manufacturing.
Recall #B-090/098-0.
CODE
Contact FDA, Center for Biologics Evaluation and Research, Office
of Compliance (301) 827-6220 for individual unit numbers recalled
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by telephone on June 26, 1998, July 13 and 14,
1998, and/or by letters on July 17 and 21, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Ohio, Michigan, Idaho, Missouri, California, Switzerland.
QUANTITY
a) 1 unit; b) 186 units; c) 52 units; d) 151 units; e) 161 units;
f) 31 units; g) 78 units; h) 22 units; i) 6 units were
distributed.
REASON
Blood products were not tested for the HIV-1 p24 antigen in
accordance with the test kit manufacturer's instructions.
________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced;
c) Platelets; d) Platelets, Pheresis; e) Cryoprecipitated AHF; f)
Plasma, Cryo Poor; g) Recovered Plasma;
h) Red Blood Cells for Manufacturing Use Only;
i) Recovered Plasma Liquid For Manufacturing Non-Injectable;
j) Platelets for Use in Manufacturing Non-Injectable Products.
Recall #B-107/116-0.
CODE
Unit Numbers: a) 249279, 265000, 291998, 298140, 348672
b) 334033; c) 249279, 265000, 298140, 334033, 348672
d) 207400, 218802, 226184, 232371, 243800, 251608, 342920,
346872; e) 291998; f) 291998; g) 249279, 265000, 298140, 334033,
348672, 207400, 243800, 346872; h) 278812;
i) 185666, 194326, 194936, 196973, 197389, 197593, 198549;
j) 196973, 268911, 278812, 323836.
MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by letters dated June 15, 21, 28, 1999, and August
9, 1999. Firm-initiated recall complete.
DISTRIBUTION
California, Florida, Minnesota, New Jersey, Pennsylvania,
Switzerland.
QUANTITY
a) 5 units; b) 1 unit; c) 5 units; d) 8 units; e) 1 unit; f) 1
unit; g) 8 units; h) 1 unit; i) 7 units; j) 4 units were
distributed.
REASON
Blood products tested negative for the antibody to the human
immunodeficiency virus type 1/2 (anti-HIV-1/2), but were
collected from donors who previously tested repeatedly reactive
for anti-HIV-2.
________
PRODUCT
Recovered Plasma. Recall #B-128-0.
CODE
Unit #30GH25982.
MANUFACTURER
American National Red Cross, Ashley, Pennsylvania.
RECALLED BY
Manufacturer, by questionable plasma inquiry forwarded on March
11, 1998. Firm-initiated recall complete.
DISTRIBUTION
Switzerland.
QUANTITY
1 unit was distributed.
REASON
Blood products were collected from a donor diagnosed with Mycosis
Fungoides.
________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall #B-130-0.
CODE
Unit #19236-2697.
MANUFACTURER
United Blood Services, Reno, Nevada.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated
September 14, 1999. Firm-initiated recall complete.
DISTRIBUTION
Nevada.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had an elevated body
temperature.
________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall #B-138-0.
CODE
Unit Numbers:
16333-7131, 16333-7132, 16333-7133, 16333-7134, 16334-5938,
16340-5551, 16340-5896, 16340-5897, 16340-5899, 16340-5900,
16340-5901, 16340-6282, 16340-7565, 16340-8695, 16340-8708,
16341-3035, 16341-3100, 16341-3102, 16341-3104, 16342-0096,
16342-0097, 16342-0098, 16342-0099, 16342-0101, 16342-0352,
16342-8743, 16343-6682, 16343-6683, 16343-6684, 16343-6685,
16343-6687, 16343-8624, 16343-8626, 16344-2112, 16344-2113,
16344-3545, 16344-3041, 16344-3042, 16344-3043, 16344-4445,
16344-4446, 16344-4447, 16344-9258, 16344-9259, 16344-9261.
MANUFACTURER
Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on
September 18, 1998, and/or letter dated October 1, 1998. Firm-
initiated recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
45 units were distributed.
REASON
Red Blood Cells, leukoreduced by filtration greater than 72 hours
past the time of collection, were distributed for transfusion.
________
PRODUCT
Red Blood Cells, Irradiated, Low Volume. Recall #B-145-0.
CODE
Unit Numbers: 22LY61409, 22LQ68923, 22LQ69111, 22KC06664,
22KY29843.
MANUFACTURER
American National Red Cross, Philadelphia, Pennsylvania.
RECALLED BY
Manufacturer, by telephone and by fax on March 26, 1999. Firm-
initiated recall complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
5 units were distributed.
REASON
Blood products were labeled with extended expiration dates.
________
PRODUCT
Red Blood Cells. Recall #B-205-0.
CODE
26159-4806, 26159-4808, 26159-4814.
MANUFACTURER
United Blood Services, Fort Smith, Arkansas.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on
September 13, 1999. And by letter dated September 21, 1999.
Firm-initiated recall complete.
DISTRIBUTION
Arkansas and Oklahoma.
QUANTITY
3 units were distributed.
REASON
Blood products were labeled with extended expiration dates.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________
PRODUCT
Stealth Surgical Clamps, indicated for surgical clamping during
cardiovascular, peripheral vascular, and general surgery: a)
Model No. A3220; Model No. A3219.
Recall #Z-207/208-0.
CODE
a) Lot Nos. E9C012, E9C083, E9C084, 99E040, 99E419;
b) Lot Nos. E9C014, E9C015, E9C087, 99F476, 99E418, 99E417.
MANUFACTURER
Applied Medical Resources, Laguna Hills, California.
RECALLED BY
Manufacturer, by fax on August 11, 1999, and by voice mail.
Firm-initiated recall ongoing.
DISTRIBUTION
Michigan, Mississippi, New York, Ohio, Texas.
QUANTITY
a) 71 clamps; b) 418 clamps were distributed.
REASON
The clamps have a potential for misalignment under high pressure
which could cause the clamps to release prematurely or to tear
the tissue held by the clamp.
________
PRODUCT
Nellcor Puritan Bennett 740 Ventilator and 760 Ventilator System.
Recall #Z-209/210-0.
CODE
All ventilators that operate at the consignee at a main voltage
of 110v.
MANUFACTURER
Nellcor Puritan Bennett Ireland, Galway, Ireland.
RECALLED BY
Mallinckrodt, Inc., St. Louis, Missouri, by letter dated
September 24, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
2,359 ventilators were distributed.
REASON
Battery power can deplete when power supply switches voltage due
to spikes.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________
PRODUCT
Spinal Anesthesia Tray, a sterile, disposable, single use device
for the administration of spinal anesthesia.
Recall #Z-206-0.
CODE
Catalog #407225, Lot #8H300 EXP 8/99.
MANUFACTURER
North American Sterilization and Packaging, Franklin, New Jersey.
RECALLED BY
Becton Dickinson Anesthesia Systems, Franklin Lakes, New Jersey,
by telephone on October 9, 1998, followed by letter on November
10, 1998. Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
Firm estimated that 218 trays remained on market at time of
recall initiation.
REASON
The vials of Tetracaine included on the tray has an expiration
date of 4/99, while the trays are dated with an expiration of
8/99. There is a possibility that expired drug could be used
resulting in ineffective anesthesia.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS - CLASS II
________
PRODUCT
Products sold under Feedstuffs Processing Co. Label:
1. Lactation Sow Cone
2. Feed Yeast
3. E$scape 200
4. Gilbert Medicated Rumensin Pellets
5. Vitamin B Premix
6. Deccox Pellets
7. Special H/B Red Supplement
8. Special H/B Green - Chicken
9. Nufac 50
10. Modesto Milling Rumensin
11. Dog Food Supplement
12. 2:1 Calcium/Phos+
13. l:l Supplement + No salt
14. Quam-Brodsky Dry Cow
15. Escape 60
16. 60-40 Protein Mix
17. Horse Supplement #5000
18. Natures Best Ocean Pellet Premix
19. Lawleyís Eliminator
20. Dairy Mineral 50
21. Barreto & Silveira Fresh Cow
22. Fawcett Heifer Mineral
23. Rumensin 1200
24. Berkeley Farms Protein/Buffer
25. Fawcett Prot/Min/Buffer Premix
26. G&D Diary Close Up Mineral
27. Brichetto Rumensin Premix
28. Whitney Oaks Dry Cow W/BDG
29. Triangle M Protein/Mineral
30. Rau Dairy Close-Up Mineral
31. Whitney Oaks By-Pass Protein
32. Kennedy/Buffer #2
33. Hillside/Springer Dry Cow
34. Hurtgen-Ve Dairy Min
35. Fertile Egg VTM Premix
36. E H Smith Lactation Mineral
37. Mendes Protein Buffer. Recall #V-001/037-0.
CODE
1055, 17255, 24105LL, 1747, 17308, 17453, 3608, 1060
17810, 19175, 17846, 17663, 19150, 3548, 3445, 18703
17804, 16612YST, 16512, 16511, 1065, 1030, 17305
2693, 2692, 2721, 509, 19200A, 1021, 507, 506, 15035
13001, 4200, 19251, 12506, 15035. Products distributed between
January 2, 1999 and July 28, 1999.
MANUFACTURER
Feedstuffs Processing Company, Turlock, California.
RECALLED BY
Manufacturer, by telephone followed by letter on August 19, 1999.
Firm-initiated recall complete.
DISTRIBUTION
California, Nevada, Guam.
QUANTITY
Undetermined.
REASON
Products may have been contaminated with high levels of selenium.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS - CLASS III
________
PRODUCT
Metabalance 25/45 M-8030 Medicated Hog Feed (Carbadox).
Recall #V-050-0.
CODE
CH0609PEL.
MANUFACTURER
Consolidated Nutrition, Camp Hill, Pennsylvania.
RECALLED BY
Manufacturer, by telephone on May 6&7, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Pennsylvania and Maryland.
QUANTITY
198 50-pound bags were distributed.
REASON
Feed was labeled to contain Carbadox, but actually contained ASP
(chlortetracycline/suflamethazine/penicillin) - Feed was labeled
incorrectly.
END OF ENFORCEMENT REPORT FOR NOVEMBER 24, 1999.
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