FDA WARNING_LETTER - Rocky Mountain Veterinary Services, Inc.

On June 22, 2015, an FDA investigation of Dr. Crandall's veterinary practice revealed violations concerning the extralabel use of PenOne Pro Penicillin G Procaine (NADA 065-010). The investigation found that the drug was rendered unsafe and adulterated under sections 512(a)(1) and 501(a)(5) of the FD&C Act, respectively, due to non-compliance with 21 C.F.R. Part 530, Extralabel Drug Use in Animals.

Specifically, Dr. Crandall prescribed PenOne Pro extralabelly for lameness and metritis in three cows (ear tags (b)(4), (b)(4), and (b)(4)). The prescribed dose of 60 ml, based on an average 1,500 lb cow, resulted in dosages of approximately 6.7 cc/100 lb and 7.3 cc/100 lb for an 896 lb and an 822 lb cow, respectively, which did not align with the FARAD recommendation of 4 cc/100 lb. Additionally, Dr. Crandall failed to consult FARAD regarding the specific brand's extended-release properties, which could affect withdrawal times.

Furthermore, Dr. Crandall failed to assure that the extralabel use would not result