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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities for April and May 2007

FDA Veterinarian Newsletter 2007 Volume XXII, No II

Warning Letters

A WARNING LETTER was issued to Leonard D. Hoekstra, president of Doon Elevator Company, Doon, IA, for significant deviations from the current Good Manufacturing Practice (cGMP) regulations for medicated feeds (21 CFR Part 225). The deviations caused the feeds being manufactured at this facility to be adulterated under Section 501(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA). FDA’s investigation revealed the following: medicated feeds had been manufactured containing the combinations of chlortetracycline with carbadox and penicillin with carbadox, and neither of these combinations is approved; the production records are not adequate to facilitate a recall of specific batches of medicated feeds, if necessary; and deliveries of bulk medicated feeds were not adequately labeled to ensure the proper use of the feed (e.g., the labeling accompanying bulk medicated feeds did not contain feeding directions or the indications for use statement).

Residues of the drug, gentamicin, in the kidney tissues of two calves offered for sale as food led to the issuance of a WARNING LETTER to Manuel Carrizales of Hereford, TX. There is no tolerance for residues of this drug in the edible tissues of bovine animals (21CFR 556. 300) and, therefore, the animals were adulterated within the meaning of Section 402(a) of the FFDCA. In addition, Mr. Carrizales was cited for offering for slaughter as food another calf that contained the drug ivermectin in the liver and muscle tissue at concentrations of 0.114 parts per million (ppm) and 0.023 ppm, respectively. By regulation (21 CFR 556.344), the established tolerance for ivermectin in the edible tissue of cattle is 0.1 ppm in the liver and 0.01 ppm in the muscle. As a result, this animal was also deemed adulterated under Section 402(a) of the FFDCA.

Merle W. Young, Jr., owner of the Young View Farm, West Glover, VT, received a WARNING LETTER for offering animals for sale for slaughter as food that were adulterated under Section 402(a) of the FFDCA. Specifically, tissue sampling conducted by the U.S. Department of Agriculture (USDA) revealed the presence of 0.622 ppm of the drug, flunixin, in the liver tissue of one of the slaughtered cows. A tolerance of 0.125 ppm has been established in 21 CFR 556.286 for residues of this drug in the liver tissues of cattle. Tissues taken from a second cow that was offered for slaughter as food revealed the presence of 8.54 ppm of the drug neomycin in the kidney tissue. A tolerance of 7.2 ppm has been established for residues of this drug in kidney tissue of cattle (21 CFR 556.430). Mr. Young was also cited in the WARNING LETTER for using both drugs extralabel in violation of Section 512 of the FFDCA and of 21 CFR 530, in that the use was not by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.

A WARNING LETTER was issued to David Tucker Purchase, co-owner of Fairmont Dairy LLC of Craftsbury, VT, for marketing two animals for sale as food in violation of the adulteration provisions of Section 402(a) of the FFDCA. The investigation by FDA also revealed that the firm caused the new animal drugs penicillin G procaine and flunixin meglumine injection to be unsafe under Section 512(a) and adulterated within the meaning of section 501(a)(5) of the FFDCA. Specifically, a dairy cow offered for slaughter was found to have 0.22 ppm of penicillin in the kidney tissues. Pursuant to 21 CFR 556.510, a tolerance of 0.05 ppm has been established for residues of this drug in the edible tissues of cattle. A second dairy cow offered for slaughter was found to have 0.234 ppm of flunixin in the liver tissue. Pursuant to 21 CFR 556.286, a tolerance of 0.125 ppm has been established for residues of this drug in the liver of cattle. FDA also determined that the firm administered penicillin G procaine without following the dosage level and duration of treatment for cattle 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). In addition, the Fairmont Dairy administered flunixin meglumine without following the route of administration for beef and dairy cattle set forth in the approved labeling and did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, the dairy’s extralabel use of these drugs resulted in illegal drug residues, in violation of 21 CFR 530.11(d). Because the extralabel use of these drugs was not in compliance with 21 CFR Part 530, the drugs were unsafe under Section 512(a) and were adulterated within the meaning of section 501(a)(5) of the FFDCA.

Similar violations were cited in a WARNING LETTER issued to Leonard M. Giglio, owner of Rockland Farm of Bolton, CT, for marketing a dairy cow for slaughter that was adulterated under section 402(a) of the FFDCA. Samples from the animal revealed the presence of residues of the new animal drug, gentamicin sulfate, in the kidney tissue. No tolerance has been established for residues of this drug in the uncooked edible tissues of cattle. The farm was also cited for lacking adequate recordkeeping systems and for not using gentamicin sulfate by or on the order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. This violated Section 512(a) of the FFDCA and also 21 CFR 530.

Ferdinand M. Ritsema, owner of the Lakin Dairy of Lakin, KS, received a WARNING LETTER from FDA for violations of the safety and adulteration provisions of Sections 512 and 501(a), respectively, of the FFDCA. Specifically, Mr. Ritsema was cited for extralabel use of penicillin and sulfadimethoxine without following the parameters set forth in the Act. Penicillin was administered without following the dosage level, duration of treatment, and withdrawal period set forth in the approved labeling and without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). In addition, Mr. Ritsema administered Albon (sulfadimethoxine) to a dairy cow for a longer period of time than listed on the drug label. This cow was offered for sale for slaughter for human food. The prescription label the firm’s veterinarian affixed to the penicillin that was used listed a 10- to 14-day withdrawal time, but Albon is labeled for treatment for 5 days with a 7-day withdrawal time. Company records indicated that the animal was withheld from slaughter for 1 day after stopping treatment with Albon and penicillin. Albon is prohibited from extralabel use in lactating dairy cattle under 21 CFR 530.41(9). In addition, a number of expired new animal drugs were observed by FDA investigators in the firm’s storage room.

Violations of Sections 402(a), 512, and 501(a) of the FFDCA have been cited in a WARNING LETTER that FDA issued to the three co-owners of the Thiele Dairy in Clearwater, NE. Specifically, tissue samples collected from a dairy cow that was offered for slaughter revealed the presence of gentamicin in the kidney tissues, but no tolerance for this drug in the kidney tissues of cattle has been established in 21 CFR 556.300. Therefore, the animal was adulterated pursuant to Section 402(a) of the FFDCA. Adequate treatment records and drug inventory system were also found to be lacking. FDA investigators also found that the firm was using gentamicin extralabel without complying with Section 512(a) of the FFDCA. For example, the dairy administered gentamicin without following the veterinarian’s written instructions for type of animal and for withdrawal time, and this was done without consulting the veterinarian, i.e., without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, the dairy’s extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(c).

A WARNING LETTER was issued to Steve T. Kemp, owner of Kemp Cattle of Fort Worth, TX, for violation of Section 402(a) of the FFDCA. Specifically, the firm offered for slaughter as food a total of four calves that were found to be adulterated due to the presence of certain drugs. Tissue sampling by USDA revealed the presence in one calf of the drug penicillin at 0.45 ppm in the liver tissue and 0.11 ppm in the kidney. A tolerance of 0.05 ppm has been established in 21 CFR 556.510 for residues of this drug in the uncooked, edible tissues of cattle. Tissues samples taken from the other three calves revealed the presence of residues of the drug gentamicin in the liver and kidney of two and in the kidney of the third. There is no tolerance established for residues of this drug in the edible tissues of cattle.

Similar violations were cited in a WARNING LETTER issued to Leonard McDaniel, owner, doing business as L & M Cattle Co., of Dallas, TX. Specifically, Mr. McDaniel offered for slaughter as food three calves that were adulterated under Section 402(a) of the FFDCA because two of them contained residues of the drug gentamicin in the liver and kidney and the third calf contained gentamicin residues in the kidney tissue. As stated earlier, there is no tolerance established for residues of this drug in the edible tissues of bovine animals.

Gentamicin is also the subject of a WARNING LETTER issued to James R. Correa, D.V.M., owner of Bear Creek Veterinary Services of Merced, CA. Specifically, a USDA inspection of a dairy cow and an investigation by FDA revealed that the cow in question was raised at a farm but had been medicated; the farm used the veterinary services of Bear Creek Veterinary Services. The WARNING LETTER noted that the drug gentamicin had been prescribed extralabel for use to treat bacterial scours and septicemia in cattle, but gentamicin is not approved for this use in cattle. In addition, Dr. Correa prescribed penicillin G procaine for use at a dose exceeding the approved dosage of 1 cc per 100 lbs. The FDA investigation revealed that Dr. Correa failed to comply with Section 512(a) of the FFDCA and 21 CFR Part 530 by failing to do the following: make a careful diagnosis and evaluation of the conditions for which the drug is to be used; establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information; institute procedures to ensure that the identity of the treated animal(s) was carefully maintained; take appropriate measures to ensure that no illegal drug residues occurred in any food-producing animals subjected to the extra-label treatment; comply with the labeling requirements in 21 CFR 530.12(c) by not providing the route of administration for the drug and failing to correctly identify the animals to be treated; and establish a valid veterinarian-client-patient relationship, as set out in 21 CFR 530.3(i).

A WARNING LETTER was issued to Joe A. Sozinho and Kristy Heldman, partners of Clearview Dairy, LLC, in Jerome, ID, for offering for slaughter as food an animal that was adulterated pursuant to Section 402(a) of the FFDCA. Specifically, a USDA inspection of the slaughtered dairy cow revealed the presence of 17.91 ppm of sulfamethazine in the liver tissue and 21.22 ppm of the drug in the muscle tissue. A tolerance of 0.10 ppm has been established for negligible residues of sulfamethazine in the uncooked edible tissues of cattle, as codified in 21 CFR 556.670. In addition, the firm adulterated the new animal drug sulfadimethoxine (Albon) 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 used extralabel but not by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship as required by the FFDCA and by 21 CFR Part 530.

Daniel S. VanGrouw, owner of Dan VanGrouw Dairy, Meridian, ID, received a WARNING LETTER for offering for slaughter for food a dairy cow that was adulterated under Section 402(a) of the FFDCA. Specifically, USDA’s inspection of the animal’s tissues revealed the presence of sulfadimethoxine at 5.69 ppm in the muscle. A tolerance of 0.1 ppm has been established for residues of this drug in the edible tissues of cattle as codified in 21 CFR 556.640. 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. The firm lacked an -adequate system to ensure that medicated animals have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues, which was also a violation of Section 402(a) of the FFDCA.

Recalls

A firm-initiated Class I recall is ongoing by T.W. Enterprises, Inc., of Ferndale, WA, for 12,463 of its Beef Pizzle dog chews in a variety of sizes. The recall was begun because the product is contaminated with Salmonella. Distribution was carried out in California, Washington, Pennsylvania, Illinois, and Oregon.

A Class II recall is ongoing by Southern States Frederick Cooperative, Inc., of Frederick, MD, for 101 tons of a variety of animal feeds. The reason for the recall was that a liquid supplement was added to the feed products processed by a feed mill, and the ingredient was not declared on the labels of bulk and bagged feed. The supplement is not intended for use in some animals. Distribution was limited to Maryland.

A Class II recall of 50 50-lb. bags of Excel-R-Ate L Mixer Medicated, containing 177.78 g/ton of lincomycin, made by Suther Feeds, Inc., of Frankfort, KS, has been completed. The feed, which was distributed only in Kansas, was recalled by the firm because it was subpotent.

A firm-initiated Class II recall is ongoing by Schering-Plough Animal Health Corporation, Summit, NJ, for 12,774 syringes of its Phenylzone Oral Paste for horses; each syringe contains 6 grams of phenylbutazone. The products were made in Ireland and were distributed nationwide in the United States. The syringes were recalled because several of them contained plungers incorrectly calibrated in animal weight, rather than in grams of Phenylzone delivered.

A Class III recall has been completed by MFA, Inc., of Columbia, MO, for 131 tons of bulk feed labeled as “Bulk LVO Starter IV CSP Pellet Medicated, A Complete Starter Feed for Baby Pigs, containing 100 g/ton chlortetracycline, 100 g/ton sulfathiazole, and 50 g/ton penicillin (as procaine).” The reason for the recall was that the product was mislabeled as containing sulfathiazole, but it actually contained sulfamethazine. The firm has also completed a Class III recall of 33.7 tons of bulk feed labeled as “Bulk LVO Starter IV CSP Pellet Medicated, A Complete Starter Feed for Baby Pigs, containing 100 g/ton chlortetracycline, 100 g/ton sulfathiazole, and 50 g/ton penicillin (as procaine).” The reason for this recall was that the product was supposed to only contain AureoZol containing sulfathiazole, but Aureomix containing sulfamethazine was also used. Distribution of all of the affected products was limited to -Missouri.

A Class III recall is ongoing by Fort Dodge Laboratories, Inc., of Fort Dodge, IA, for 7,476 200-ml. bottles and 44,365 500-ml. bottles of the firm’s Cydectin, moxidectin, Injectable Solution for Beef and Nonlactating Dairy Cattle, Antiparasitic, Sterile. The reason for the recall is that the firm cannot ensure validated parameters were met in the aseptic filing room. Distribution of the products was nationwide. The company is also undertaking a Class II recall of 139 62-pouch pails of its Aureomycin Chlortetracycline Soluble Powder, for Veterinary Use in Drinking Water, containing 25 g/lb. chlortetracycline HCl. The reason for this recall was that a 9-month stability sample was out of specification (low) for chlortetracycline HCl. Distribution was nationwide and in Panama.

A Class III firm-initiated recall has been completed by MFA Inc. of Columbia, MO, for 20 50-lb. bags of Muscle Pig IV CSP and 5,840 lbs. of bulk Muscle Pig III CSP that are mislabeled as containing sulfathiazole, when they actually contain sulfamethazine. This firm also completed a Class III recall of 3,900 lbs. of bulk and 235 of its 50-lb. bags of Muscle Pig III and 350 of its 50-lb. bags of Muscle Pig IV for the same reason. Additionally, a Class III recall of 229 of its 50-lb. bags of Muscle Pig IV and of 60 of the firm’s 50- lb. bags of Muscle Pig III was completed. This product was supposed to only contain AureoZol containing sulfathiazole, but Aureomix containing sulfamethazine was also used. Distribution of all of the recalled products was limited to -Missouri.