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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities – March - July 2008

FDA Veterinarian Newsletter 2008 Volume XXIII, No II

Recalls

Hartz Mountain Corporation of Secaucus, NJ, is carrying out a firm-initiated Class I recall of 888 bottles of Hartz Vitamin Care for Cats and Kittens chewable tablets. The product, which was distributed nationwide, tested positive for the pres-ence of Salmonella.

Purina Mills LLC d/b/a Land O’Lakes Purina Feed LLC, Camp Hill, PA, is carrying out a Class II, firm-initiated recall of 100,450 bags of 68 different animal feed products for horses, cattle, dear, lambs, and pigs that were distributed nation-wide. The products are being recalled because they contain elevated levels of aflatoxins.

A Class II firm-initiated recall is ongoing by Smiths Medical PM, Inc., Waukesha, WI, for 16 units of the SurgiVet V6004 NIBP Monitor. The tantalum capacitor located at C5 on the V64004 display board of the Smith Medical PM, Inc., BCI® Mini-Torr Plus® NIBP Monitor with SpO2 Built-In Printer, may be reverse polarized. As a result the monitor might turn off or the monitor might immediately reset. The affected units were distributed in Alabama, Louisiana, New Mexico, Pennsyl-vania, Texas, Wisconsin, Canada, Ecuador, and Hong Kong.

A Class III firm-initiated recall has been completed by Cargill, Inc., of Billings, MT, for more than 34 tons of lamb, sheep, cattle, and llama feed because the products contained excessive and undeclared amounts of chlortetracycline. Distribu-tion had been in Montana and Wyoming.

Milbank Mills, Inc., of Chillicothe, MO, is carrying out a firm-initiated Class III recall of two of its medicated feeds under its Silver Moon Feeds label. The products in question involve 73 10-lb. bags, 47,760 lbs. in bulk, and 2,219 50-lb. bags. The products, which were distributed in Missouri and Iowa, are being recalled because the incorrect bag tag was used.

IVX Animal Health, Inc., of St. Joseph, MO, is conducting a firm-initiated Class III recall of approximately 19,500 bottles of sterile aqueous solution products for animal use under the VetTek brand. The products, which were distributed only in Missouri, are being recalled due to a lack of sterility assurance.

A Class III firm-initiated recall has been completed by CP Medical of Portland, OR, for 878 boxes (12 packages in each box) of Polydioxanone (PDO) Monofilament Synthetic Absorbable Sterile Sutures. The recall was carried out because the package is labeled for a 37 mm 1/2 circle cutting needle, but may contain a 37 mm tapered needle. Distribution took place in Arizona, Michigan, Missouri, Nebraska, Nevada, Texas, and Israel.

Qualis Group LLC of Des Moines, IA, is carrying out a firm-initiated Class III recall of approximately 900 containers of Dionne Foot Rot Treatment Topical Antiseptic. The reason for the recall was that the active ingredient, iodine, failed stabil-ity testing. Distribution of the products took place in Illinois, Missouri, Washington, Oklahoma, North Carolina, Iowa, Ten-nessee, and South Dakota.

More than 61 million units of non-domestic bird food and other wild animal feed are the subject of an ongoing, firm-initiated Class III recall by Scotts Miracle Gro, Canal Winchester, OH. The products were distributed nationwide and are being recalled because the food and feed products were found to have been treated with pesticides that were not labeled with instructions for approved use only on wild bird or wild animal products or on all of the individual components that might be present in such stored grain mixtures.

Central Connecticut Cooperative Farmers Association, Manchester, CT, has completed a Class I firm-initiated recall of 5,870 lbs. (bulk and 50-pound bags) of 12% Equinator Integrity Horse Pellets that were distributed in the state. The rea-son for the recall was that the horse feed was contaminated with medication not approved for use in horses.

A total of 44,675 units of DVMax Ointment, Gentamincin Sulfate, USP, Betamethasone Valerate, USP, and Clotrima-zole, USP Ointment, packaged in 10-gm, 20-gm, and 215-gm containers are the subject of a firm-initiated, ongoing Class II recall by IVX Animal Health Inc., St. Joseph, MO. The products, which were distributed nationwide, may not meet ho-mogeneity specifications.

A Class III firm-initiated recall is ongoing by Southern States d/b/a Cooperative Milling, Inc., Gettysburg, PA, involving 1,142 bags of pelleted horse and sheep feeds. The products, which were distributed in Delaware, Maryland, New Hamp-shire, New Jersey, New York, Pennsylvania, and Virginia, were recalled due to elevated aflatoxin levels.

Warning Letters

FDA has sent a WARNING LETTER to Barry J. Paskewitz, Redwood Falls, MN, for violations of the adulteration provi-sions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifically, Mr. Paskewitz’s cattle operation consigned a livestock hauler to transport 36 cows for slaughter as food. Inspection by the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA/FSIS) yielded the presence in one of the cows of residues of penciling in the kidney tissue at 0.21 parts per million (ppm). A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle (21 CFR 556.510). This excess amount of the drug in the tissues caused the animal to be adulter-ated under section 402(a) of the FFDCA. FDA’s investigation also found that this firm held animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues could enter the food supply. The WARNING LETTER also cited Mr. Paskewitz for lacking a system to ensure that animals he buys, feeds, and then sells for slaughter as food have not been medicated or, if they have been medicated, to allow the firm to withhold the animals from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues.

John D. Johnson, owner of the Johnson Dairy of Eaton, CO, received a WARNING LETTER for violations of the same adulteration provision of the FFDCA involving the sale of four different animals. Specifically, this firm sold a Holstein cow for slaughter as food that was found to have flunixin in the muscle tissue at 0.061 ppm and in the liver tissue at 0.570 ppm. A tolerance of 0.025 ppm has been established for residues of this drug in the edible muscle tissues of cattle and 0.125 ppm in the edible liver tissue of cattle (21 CFR 556.286). The presence of these excess levels of flunixin in the ani-mal tissues caused the animal to be adulterated under section 402(a) of the FFDCA. A second Holstein cow was found to have residues of sulfadimethoxine in the liver tissue 0.12 ppm, thereby exceeding the established tolerance of 0.10 ppm as codified in 21 CFR 556. 640. A third Holstein cow was found to have residues of flunixin in the liver tissue at 0.341 ppm, exceeding the established tolerance of 0.125 ppm set forth in 21 CFR 556.286. A fourth Holstein cow was found to have residues of flunixin in the muscle tissue at 0.270 ppm and in the liver tissue at 4.912 ppm, exceeding the established tolerances of 0.025 ppm and 0.125 ppm, respectively (21 CFR 556.286). Adequate treatment records were also found to be lacking.

A WARNING LETTER has been sent by FDA to Frank and Mary Arburua, co-owners of the Pyrenees Dairy in Chino, CA, for violations of the adulteration provisions of the FFDCA. Specifically, the dairy sold three cows on three different dates and all were found to contain residues of penicillin in the kidney and liver tissues, respectively, as follows: 0.44 ppm in the kidney, 0.24 ppm in the liver; 0.28 ppm in the kidney, 0.17 ppm in the liver; and 0.19 ppm in the kidney, and 0.07 ppm in the liver. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle (21 CFR 556. 510), thus rendering the three cows adulterated under section 402(a) of the FFDCA. In addition, the firm was found to lack adequate animal treatment records and was also found to be in violation of the extralabel use provisions of the Act (sections 512(a) and 501(a)).

Violations of the adulteration provisions in the FFDCA also led to the issuance of a WARNING LETTER by FDA to Richard Van Dyk, owner of the Van Dyk Dairy #1, Jerome, ID. Specifically, the company sold a dairy cow for slaughter as food that was found to contain residues of the drug sulfadimethoxine at 0.14 ppm in the liver tissue. A tolerance of 0.1 ppm has been established for residues of this drug in the edible uncooked liver tissue of cattle (21 CFR 556.640). USDA’s sampling also revealed the presence of the drug sulfamethazine in the same animal at 0.46 ppm in the liver tissue and 0.19 ppm in the muscle tissue; there is no established tolerance for sulfamethazine in lactating dairy cows. The presence of these drugs at inappropriate levels rendered them adulterated under section 402(a) of the FFDCA. In addition, the firm was found to have adulterated the drug Sustain III (sulfamethazine) Bolus within the meaning of section 501(a) of the FFDCA by failing to use the drug in conformance with its approved labeling. Treatment records were also found to be lacking.

FDA issued a WARNING LETTER to John and Maria Nunes, co-owners of the John and Maria Nunes Dairy, Turlock, CA, for violations of the adulteration provisions of the FFDCA. Specifically, the dairy consigned a dairy cow for slaughter as food that contained residues of the drug, gentamicin, in the kidney tissue. No tolerance for residues of this drug has been established by FDA (21 CFR 556.300), thereby rendering the animal adulterated under section 402(a) of the Act. In addition, because the firm provided a signed certification that no animal would be supplied containing any illegal drug residues, it was found in violation of section 301(h) of the FFDCA (providing a false guaranty). In addition, the dairy adul-terated the new animal drugs, Legacy Gentamicin Sulfate Solution, Duramycin 100 Oxytetracycline Hydrochloride Injec-tion, Sulfadimethoxine Injection 40%, Albon Sulfadimethoxine Boluses, and PEN-AQUEOUS Penicillin G Procaine, In-jectable Suspension U.S.P., within the meaning of section 501(a) of the FFDCA by failing to use the drugs in conformance with their approved labeling.

John and Jolene Schoneveld and Martin and Alice Bouma, co-owners of the Lakeview Dairy Farms, Bakersfield, CA, have received a WARNING LETTER from FDA for violations of the adulteration provisions of the FFDCA. Specifically, the dairy consigned a dairy cow for sale at auction for slaughter as food. FSIS sampling revealed the presence of the drug flunixin in the liver at 0.448 ppm and in the muscle tissue at 0.063 ppm. A tolerance of 0.125 ppm in the liver and 0.025 ppm in the muscle tissue has been established for residues of this drug (21 CFR 556.286). The excess levels thereby rendered the animal adulterated pursuant to section 402(a) of the Act. The firm was also found to have adulterated Flunixin Meglumine Injectable Solution under section 501(a) of the FFDCA by failing to use the drug in conformance with its approved labeling. The firm also failed to maintain complete treatment records for the operation.

A WARNING LETTER has been issued to Gerald L. Gilbert, president of Country Morning Farms, Warden, WA, for vio-lations of the adulteration provisions of the FFDCA. Specifically, the farm consigned one dairy cow for slaughter as food that contained residues of the drug sulfadimethoxine in the liver tissue at 14.45 ppm. A second dairy cow that was also consigned for slaughter as food contained residues of the same drug in the liver tissue at 5.81 ppm. A tolerance of 0.1 ppm has been established by FDA for residues of sulfadimethoxine in the edible tissues of cattle (21 CFR 556.640(b)), rendering both cows adulterated under Section 501(a)(5) of the FFDCA. The dairy was found to have not used the drug in conformance with its approved labeling. The drug was administered at a higher dosage than indicated on the approved label, and the dairy did not observe the pre-slaughter withdrawal period required by the label.

FDA has sent a WARNING LETTER to Neil and Paul Chelton and Chad Keeler, co-owners of Pal-Nel Farms, Corry, PA, for violations of the adulteration provisions of the FFDCA. The farm consigned two bob veal calves for slaughter as food. FSIS samples taken of them revealed the presence of 272.43 ppm neomycin in the kidney tissue of one animal and 134.44 ppm neomycin in the kidney tissue of the other one. A tolerance of 7.2 ppm has been established by FDA for resi-dues of this drug (21 CFR 556.430), thereby rendering the two animals adulterated under Section 402(a) of the Act. Fail-ure to follow drug withdrawal times and violations of the extralabel use provisions as set forth in 21 CFR 530 were also cited in the WARNING LETTER.

Violations of Section 402(a) of the FFDCA were also cited in a WARNING LETTER issued by FDA to Chris Cole, owner of the A.B. Cole Dairy Farm, Meshoppen, PA. Specifically, the dairy consigned a bob veal calf to be slaughtered for food. Sampling revealed the presence of the drug sulfamethazine in the muscle tissue of the calf at 46.18 ppm and in the liver tissue at 36.41 ppm. A tolerance of 0.1 ppm has been established by FDA for residues of this drug in the uncooked edible tissues of cattle (21 CFR 556.670), thereby rendering the animal adulterated. FDA’s investigation also found that the dairy held animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. An adequate system to ensure that animals medicated by the dairy have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues was lacking.

Jonathan J. Glick, owner of a dairy operation in Howard, PA, has received a WARNING LETTER from FDA for viola-tions of the adulteration provisions of the FFDCA. Specifically, the dairy sold a cow for slaughter as food that was found to contain residues of the drug sulfadimethoxine in liver tissue at 3.05 ppm and in the muscle tissue at 1.41 ppm. A tolerance of 0.1 ppm has been established by FDA for residues of this drug in the uncooked edible tissues of cattle (21 CFR 556.640), rendering the animal adulterated under Section 402(a) of the Act. FDA’s investigation also found that the firm held animals under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply.

FDA has issued a WARNING LETTER to Phil G. Mlsna, president of Mlsna Dairy Supply, Inc., Cashton, WI, for viola-tions of the adulteration provisions of the FFDCA. Specifically, the dairy consigned to a hauler a dairy cow that was found to have 0.128 parts per million (ppm) of the drug, flunixin, in the liver tissue. A tolerance of 0.125 ppm has been estab-lished for residues of this drug in the liver of cattle (21 CFR 556.286(b)(1)(i)). The presence of the excess amount of flunixin caused the cow to be adulterated under Section 402(a) of the FFDCA. The dairy was also found to adulterated sulfadimethoxrine and flunixin meglumine within the meaning of section 501(a)(5) of the FFDCA when it failed to use these drugs in conformance with their approved labeling. Specifically, the extralabel use requirements were not followed appropriately.

Ronald P. St. John, managing partner of Alliance Dairies, Trenton, FL, has received a WARNING LETTER from FDA for offering for slaughter an adulterated animal. Specifically, the dairy sold a cow for slaughter as food that was later found to contain residues of penicillin in the kidney tissue at 0.17 ppm. A tolerance for this drug of 0.05 ppm has been estab-lished (21 CFR 556.510), rendering the animal adulterated under Section 402(a) of the FFDCA. The firm was also found to have adulterated the new animal drugs penicillin and tylosin within the meaning of Section 501(a)(5) of the Act when it failed to use them in accordance with their approved labeling. The firm was also found to have provided a false guaranty in violation of Section 301(h) of the FFDCA.

Adulteration violations were also cited in a WARNING LETTER from FDA to Jerry Harris, owner of Harris Dairies, Ris-ing Star, TX. The firm sold a Holstein dairy cow for slaughter as food that was later found to have residues of the drug sul-fadimethoxine at 0.13 ppm in the liver tissue. A tolerance of 0.1 ppm has been established for residues of this drug in the edible tissues of cattle (21 CFR 556. 640(b)(1)), thus rendering the animal adulterated under Section 402(a) of the FFDCA. In addition, the firm adulterated a brand of sulfadimethoxine antibacterial soluble powder within the meaning of section 501(a)(5) of the FFDCA when it failed to use the drug in conformance with its approved labeling with respect to extralabel uses.

Daniel Logue, president of the Central Connecticut Cooperative Farmers Association, Manchester, CT, has received a WARNING LETTER for violations of the safety and adulteration provisions of the FFDCA. Specifically, samples of the firm’s equine feed, 12% Equinator Integrity Horse Pellets, BH716, were found to contain the new animal drugs lasalocid sodium and salinomycin, neither of which is approved by FDA for use in equine feed. The presence of the drugs rendered the equine feed unsafe under Section 512(a)(2) of the Act and adulterated under Section 501(a)(6) of the Act.

A WARNING LETTER has been issued to Gary Domina of Enosburg Falls, VT, for violations of the adulteration provi-sions of the FFDCA. According to the letter, he offered an animal for slaughter for sale as food that contained residues of the drug dihydrostreptomycin in the kidney tissue at 9.78 ppm. A tolerance of 2.0 ppm has been established for residues of this drug in the kidney of cattle (21 CFR 556.200)). In addition, FDA’s investigation found that Mr. Domina adulterated the new animal drug dihydrostreptomycin within the meaning of section 501(a)(5) of the Act when he failed to use this drug in conformance with its approved labeling. The approved application for this drug, Quartermaster brand of dihy-drostreptomycin, restricts this drug to use by or on the order of a licensed veterinarian. The use of this drug was not by or on the order of a licensed veterinarian, and because the use of this drug deviated from its approved application, the drug was unsafe under section 512(a)(1)(A) of the FFDCA and the use caused it to be adulterated within the meaning of sec-tion 501(a)(5) of the Act.