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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities for February and March 2007

FDA Veterinarian Newsletter 2007 Volume XXII, No I

Warning Letters

A WARNING LETTER was issued to Edgar L. Erlanger, president of Nich Marketers, Inc., of Columbus, OH, for marketing adulterated new animal drugs in violation of Section 501(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA). Investigations revealed that the firm was marketing the following animal products that were not the subject of approved new animal drug applications: Sorb-A-Tox Suspension, BIS-CO-SORB Suspension, Aspir-SLO, Colloidal Silver, B-Mune™ Capsules (Beta-1,3-D glucan), Nich UAAGel® (Universal Animal Antidote Gel), and “Tongue to Tail.” A review of the firm’s Web site showed that several of the products were either labeled or promoted for a variety of animal uses. Some of the products were also found to be misbranded under Section 502 of the FFDCA because the labeling lacked adequate directions for use or a National Drug Control number

Food adulteration was cited as the basis of a WARNING LETTER issued to James L. Wilson, managing partner, and Cornelius A. Vanderham, partner, of J & D Wilson and Sons Dairy, of Riverdale, CA. Specifically, two animals offered for slaughter as food were adulterated under Sections 402(a) and 501(a) of the FFDCA. Analysis of tissue samples from the first animal by the U.S. Department of Agriculture revealed the presence of flunixin meglumine in the liver at 0.87 parts per million (ppm). A tolerance for this drug in the liver tissue of cattle has been set in 21 CFR 556.286 at 0.125 ppm. Tissue samples of the second animal revealed the presence of penicillin in the kidney at 0.36 ppm. Under 21 CFR 556.510, a tolerance level for residues of penicillin has been established for uncooked edible tissues of cattle at 0.05 ppm. The presence of these drugs in the two animals at those levels rendered the animals adulterated under Section 402(a) of the Act. In addition, the firm was warned that it adulterated the drug flunixin meglumine by failing to use it in conformance with its approved labeling, in that its extralabel use was not in compliance with Section 512(a) of the FFDCA. Similarly, the firm was also warned that it failed to use the drug penicillin-dihydrostreptomycin in conformance with its approved labeling, because the appropriate withdrawal period as set forth in the veterinarian’s written instructions was not followed.

Similar warnings were contained in a WARNING LETTER issued to Richard H. Hall, co-owner of Fairmont Farm, Inc., East Montpelier, VT, because of a violation of Section 402(a) of the FFDCA with respect to a slaughtered dairy cow. Sampling by USDA revealed the presence of 0.14 ppm of penicillin in the kidney of the cow, thus exceeding the tolerance of 0.05 ppm established in 21 CFR 556.510. In addition, the firm was warned about adulterating the drug penicillin G procaine because it was being used extralabel; specifically, the drug was not used on the order of a licensed veterinarian. The drug was used without following the dosage level and duration of treatment for cattle set forth in the approved labeling, thus causing the drug to be adulterated under Section 501(a) of the FFDCA.

Roger and Julie Lanners, owners of a dairy operation in Royalton, MN, received a WARNING LETTER because they offered for slaughter as food three dairy cows that were adulterated under Section 402(a) of the FFDCA. Specifically, tissue samples taken from the first animal revealed the presence of 27 ppm oxytetracycline in kidney tissue, 0.30 ppm sulfadimethoxine in liver tissue, and 0.82 ppm sulfadimethoxine in muscle tissue. Samples of tissues from the second animal revealed the presence of 0.11 ppm ampicillin in kidney tissue. In the third animal, samples taken revealed the presence of 20.98 ppm oxytetracycline in kidney tissue, 6.97 ppm sulfadimethoxine in liver tissue, and 3.88 ppm sulfadimethoxine in muscle tissue. A tolerance of 12 ppm has been established for residues of oxytetracycline in kidney tissues of cattle as codified 21 CFR 556.500. A tolerance of 0.01 ppm has been established for residues of ampicillin in uncooked edible tissues of cattle as codified in 21 CFR 556.40, and a tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in uncooked edible tissue of cattle as codified in 21 CFR 556.640. The presence of these drugs in excess of these amounts in tissues from the animals caused the food to be adulterated. Violations of extralabel use restrictions and proper drug residue withdrawal times were also cited in the WARNING LETTER.

A WARNING LETTER was issued to Arvis, Autic, and Jimmy Loy, president, vice president, and secretary, respectively, of Russell County Stockyards, Russell Springs, KY, because a beef cow and a bull that were offered for sale for slaughter were adulterated under Section 402(a) of the FFDCA. Specifically, tissue samples taken from the two animals revealed residues of the drug gentamicin in the kidneys; no tolerance has been established for residues of this drug in the edible tissues of cattle. During FDA’s inspection of the firm, it was also determined that Russell County Stockyards was not obtaining written statements from sellers regarding the medication status of animals it received and not inquiring about the medication status of animals sold at its auctions. Such noncompliance violates Section 301(h) of the FFDCA.

Similar violations were cited in a WARNING LETTER issued to David E. Johnson, d/b/a Joleanna Holsteins, Unadilla, NY. Specifically, the firm consigned a dairy cow to a cattle auctioneer and the cow eventually was slaughtered for human food. USDA’s analysis of tissue samples revealed the presence of 0.57 ppm penicillin in kidney tissue and 0.16 ppm penicillin in liver tissue. A tolerance of 0.05 ppm has been established for residues of penicillin in uncooked edible tissues of cattle as codified in 21 CFR 556.510. The excessive residues of penicillin resulted in the food being adulterated within the meaning of Section 402(a) of the FFDCA. Other adulteration warnings were based on the firm’s failure to maintain written treatment records to document the identity of the animal, treatment dates, drugs administered, dosage administered, route of administration, and withdrawal times for milk and beef.

Dr. Michael A. Wing of the Meadow Wood Animal Clinic, Cornville, ME, received a WARNING LETTER for causing animal drugs to be unsafe within the meaning of Section 512(a) and adulterated under Section 501(a) of the FFDCA because the drugs were used in a manner that did not conform to their approved applications. In addition, Dr. Wing’s actions caused two animals that were slaughtered as food to be adulterated under Section 402(a) of the Act. A tissue sampling of one of the animals in question revealed the presence of residues of flunixin, which had been prescribed by Dr. Wing, in the amount of 3.372 ppm in the liver of a dairy cow. A tolerance of 0.125 ppm flunixin has been established in 21 CFR 556.286. Dr. Wing was also warned about being in violation of the extralabel drug use regulation (21 CFR 530) by not establishing a substantially extended withdrawal period prior to marketing of edible products, and for failure to institute procedures to ensure that the identity of the treated animal or animals is carefully maintained.

Recalls

A Class I firm-initiated recall is ongoing by Wild Kitty Cat Food, Inc., Arundel, ME. The recall involves the following items: (1) Wild Kitty Cat Food-Raw All Natural Chicken with Clam Recipe, Plastic 3.5 oz. (100g) and 16 oz. (1 lb.) units packaged in plastic; (2) Wild Kitty Cat Food-Raw All Natural Duck with Clam Recipe, Plastic 3.5 oz. (100g) and 16 oz. (1 lb.) units packaged in plastic; and (3) Wild Kitty Cat Food-Raw All Natural Tuna with Conch Recipe, Plastic 3.5 oz. (100g) packaged in plastic. The recall was launched because of possible contamination with Salmonella, and involves 29,258 3.5-oz. packages, and 3,642 1-lb. packages of the cat food. Distribution of the products affected by the recall is taking place in the following states: Connecticut, Florida, Illinois, Massachusetts, Maryland, Maine, Michigan, New Mexico, New Jersey, New York, and Washington.

A Class II firm-initiated recall is ongoing by Pfeifer Arno, Inc., Greenbush, WI, of bulk cattle feed made with recalled Darling’s 85% Blood Meal, Flash-Dried. The blood meal used to make the recalled cattle feed was itself recalled because it was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured using common equipment, and -labeling did not bear the cautionary BSE statement. The recall involves 42,090 lbs. of feed that was limited to distribution in Wisconsin.

Rangen, Inc., Buhl, ID, has completed a Class II recall of almost 1 million pounds of feed products manufactured from bulk feed containing blood meal that was cross-contaminated with prohibited meat and bone meal, and the labeling did not bear the cautionary BSE statement. Distribution of the recalled products was limited to Idaho and Nevada.

A firm-initiated Class II recall is ongoing by Protient, Inc., Saint Paul, MN, involving 90,000 lbs. of Utah Proteins (the manufacturer) Sweet Dairy Whey (Edible Grade) held in paper bags with a polyethylene liner. The recall is being carried out because one of the whey powder ingredients may be contaminated with Salmonella. Distribution was limited to California, Nevada, and Utah.

A Class II firm-initiated recall has been completed by Eatonton Co-Op Feed Co., Eatonton, GA, involving its dairy cattle feed blends containing ProLak and/or ProAmino II protein concentrate that was manufactured in April 2006. The recall, which involved 25 tons of material, was carried out because the finished feed product was manufactured from raw feed material that may have been contaminated with ruminant-derived protein. Distribution was limited to Georgia.

Golden Rod Feed Mill, Inc., of Cullman, AL, has completed a firm-initiated Class II recall of 52,500 lbs. of Broiler Grower, 200-118-101, medicated bulk poultry feed that contained excessive amounts of sodium. Distribution of the product was limited to Alabama.

A Class II recall is ongoing by Darling National LLC of Omaha, NE, involving 1.36 million pounds of its Bulk -Darling’s 85% Blood Meal, Flash Dried, distributed in totes and 1-lb. bags. Distribution took place in Wisconsin, Texas, Tennessee, Nebraska, Colorado, and Minnesota. The product is being recalled because some of the exempt bovine blood meal was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment, and the labeling did not bear the cautionary BSE statement that it should not be fed to ruminants.

A Class II recall is ongoing by Belcher Pharmaceuticals, Inc., of Largo, FL, involving 88,120 bottles of Thyroxine L (Levothyroxine Sodium Tablets, as well as Oral Solution, USP) (Veterinary). The products are being recalled because processing and cleaning procedures were not validated prior to production, and the products had some GMP failures related to the quality system. Distribution of the products in question was limited to Missouri.