FDA WARNING_LETTER - Double D Dairy - April 03, 2014

On February 21, March 24, and April 3, 2014, the FDA investigated Double D Dairy, LLC, in Weidman, Michigan, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy adulterated new animal drugs Naxcel (ceftiofur sterile powder) and Vetrimycin 100 (oxytetracycline hydrochloride injection) by using them extralabelly, not as directed by approved labeling or a veterinarian's prescription.

Specifically, Naxcel was administered without following the approved duration of treatment, which is prohibited for extralabel use in cattle per 21 C.F.R. 530.41(a)(13). Vetrimycin 100 was administered to lactating dairy cows without following the approved route of administration, animal class, and duration of treatment, and this extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). These actions rendered the drugs unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act.

The FDA acknowledged the dairy's April 14, 2014, response stating they would follow ceftiofur label directions and cease oxytetracycline use. The letter requires Double D Dairy to