FDA WARNING_LETTER - Regancrest Holsteins, Inc. - March 09, 2010

On March 8-9, 2010, the FDA investigated Regancrest Holsteins, Inc., a dairy operation in Waukon, Iowa, and found violations of the Federal Food, Drug, and Cosmetic Act. The company adulterated new animal drugs DiMethox, Agrimycin 100, and TyloVed by using them extralabelly, not as directed by their approved labeling.

Specifically, sulfadimethoxine (DiMethox) was administered to a lactating dairy cow without following the approved route of administration and conditions of use, which is prohibited for extralabel use in lactating dairy cattle (21 C.F.R. 530.41(a)(9)). Oxytetracycline (Agrimycin 100) and tylosin (TyloVed) were also administered extralabelly to lactating dairy cows without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). The extralabel use of tylosin also did not follow the approved route of administration.

These extralabel uses, not complying with 21 C.F.R. Part 530, rendered the drugs unsafe and adulterated under sections 512(a) and 501(a)(5) of the Act. Regancrest Holsteins must take prompt action to correct these violations and establish procedures to prevent recurrence. A