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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities – February 2008

FDA Veterinarian Newsletter January / February 2008 Volume XXIII, No I

Warning Letters

A WARNING LETTER was issued by FDA to Aaron G. Poupore, co-owner/herdsman of the Papas Dairy, LLC, North Bangor, NY, for violations of the adulteration provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifi-cally, the dairy sold a cow for slaughter as food that contained residues of 0.60 parts per million (ppm) of the drug sul-fadimethoxine in the liver tissue and 0.41 ppm of the same drug in the muscle tissue. A tolerance of 0.1 ppm of this drug in the uncooked edible tissues of cattle has been established by FDA (21 CFR 556.640), rendering the animal adulterated under Section 402(a) of the Act. In addition, the firm was cited for violating Section 501(a) of the Act for failing to use the drugs Albion (sulfadimethoxine boluses) and Penicillin G Procaine in conformance with their approved labeling. The WARNING LETTER also cited the dairy for failing to maintain adequate treatment records.

Francis H. Roderick of Old Carolina Farms, Ijamsville, MD, has received a WARNING LETTER for violations of Section 402(a) of the FFDCA. The firm consigned a bob veal calf for slaughter as food that was found to contain residues of the drug sulfamethazine in the liver tissue at 131.89 ppm and in the muscle tissue at 179.88 ppm. FDA has set a tolerance for this drug of 0.1 ppm (21 CFR 556.670), rendering the animal adulterated. In addition, the firm was cited for providing a false guaranty to FDA in violation of Section 301(h) of the Act, and for failing to use sulfamethazine in conformance with its approved labeling in violation of Section 501(a) of the Act. And, according to the WARNING LETTER, the firm lacked an adequate system to ensure that animals medicated have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.

FDA issued a WARNING LETTER to Dale L. Utter, owner of the Piedmont Dairy, Moore, SC, for violation of the adul-teration provision in Section 402(a) of the FFDCA. Specifically, the firm sold a dairy cow for slaughter as food that was found to have penicillin in the kidney tissues at 7.03 ppm, in the liver tissue at 0.37 ppm, and in the muscle tissue at 0.20 ppm. FDA has set a tolerance of 0.05 ppm for residues of penicillin in the edible tissues of cattle (21 CFR 556.510). As a result, the food was adulterated under Section 402(a). In addition, the firm had signed a certification, stating that the dairy was not delivering any livestock with illegal drug residues. Therefore, the firm was found to have provided a false guaranty pursuant to Section 301(h) of the FFDCA. Adequate treatment records were also found to be lacking.

Similar violations of Section 402(a) of the FFDCA were cited in a WARNING LETTER issued by FDA to Mark Gul-licksrud, president, and Gary L. Gullicksrud, vice president, of Hamlin Valley Farms, Strum, WI. Specifically, the firm con-signed a cattle trucker to transport a dairy cow for slaughter as food. Inspection revealed the presence of ampicillin in the kidney tissue of the animal at 0.06 ppm. FDA has set a tolerance for this drug in the kidney tissue of cattle at 0.01 ppm (21 CFR 556.40), thereby rendering the food adulterated under Section 402(a). The firm was also found to have adulter-ated ampicillin within the meaning of Section 501(a)(5) of the FFDCA by failing to use the drug in conformance with the conditions for extralabel used prescribed by the firm’s veterinarian. In addition, the firm provided a signed certification that stated that none of the animals it supplied contained illegal levels of drug residues, which proved to be untrue. Pursuant to section 301(h) of the Act, providing such a false guaranty is prohibited.

Fred, Scott and Trent Sherman, co-owners of the Sherman Dairy, Winton, CA, received a WARNING LETTER from FDA for offering an animal for sale for slaughter as food that was adulterated under Section 402(a) of the FFDCA. An analysis of tissue samples revealed the presence of penicillin in the kidney at 0.29 ppm; the tolerance set by FDA for penicillin in the edible tissues of cattle is 0.05 ppm (21 CFR 556.510). In addition, the firm adulterated AgriPharm PEN-AQUEOUS, Penicillin G Procaine, Injectable Suspension U.S.P. within the meaning of section 501(a)(5) of the Act when it failed to use the drug in conformance with its approved labeling. The drug was administered without following the dosage level set forth in the approved labeling and it was done without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11 (a).

A WARNING LETTER was issued to William R. Scheenstra, president of Scheenstra Farms, Inc., of Sunnyside, WA, for violation of Section 402(a) of the FFDCA. The firm sold a dairy cow for slaughter as food that was found to have resi-dues of ampicillin in the liver tissues at 0.04 ppm and in the kidney tissues at 0.70 ppm. FDA has set a tolerance for resi-dues of this drug in the uncooked edible tissues of cattle at 0.01 ppm (21 CFR 556.40), rendering the animal in question adulterated under Section 402(a). FDA’s investigation also revealed that the firm’s extralabel use of ampicillin failed to comply with section 512(a) of the FFDCA and with 21 CFR Part 530. For example, the firm administered ampicillin for a condition (mastitis) not set forth in the approved labeling and it did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, the extralabel use resulted in an illegal drug residue.

Recalls

A Class II firm-initiated recall is ongoing by Durotec USA Co. of Vancouver, WA, for 7,000 units of UDDERCARE Washing Liquid and Organic Wash. The reason for the recall is that the product, which is used for teat wash for dairy cows, is contaminated with bacteria. Distribution occurred in Washington, California, and Oregon.

A total of 772 pails (Code DC-1499) and 240 pails (Code DC-1483) of Pharmacia & Upjohn Quartermaster Suspension, penicillin-dihydrostreptomycin in oil are the subject of an ongoing, firm-initiated Class II recall by Pfizer, Inc., New York, NY. The recall was begun because the products were out of specification. The products were distributed in Iowa, Colo-rado, Idaho, Nebraska, and Texas.

A firm-initiated Class II recall is ongoing by IVX Animal Health, Inc., of St. Joseph, MO, for approximately 141,000 vials of Ivermectin Liquid for Horses (10 mg per mL) in 100-mL and 200-mL vials. The recall was begun because a precipitate forms once the bottles have been opened. The products were distributed nationwide.

A Class III firm-initiated recall has been completed by CP Medical of Portland, OR, for 547 boxes of 12-each, Mono-filament Polydioxanone Synthetic Absorbable (PDO), Sterile Suture (Violet Color) 0 (3.5 metric) 30” (75 cm) 1/2 37 mm Taper. The recall was carried out because the monofilament sutures were incorrectly labeled; specifically, the package is labeled with suture size 0 but may contain suture size 3/0. The products had been distributed in Arizona, Louisiana, Mas-sachusetts, Michigan, Missouri, North Carolina, Ohio, and Texas.