Squirt's Mom
01-24-2015, 10:49 AM
http://www.fda.gov/Safety/Recalls/ucm431425.htm
January 23, 2015 — Chester, SC — Cox Veterinary Laboratory, Inc. is
voluntarily recalling the lots of Gastroade Xtra identified below down to the consumer level
distributed nationwide. Gastroade Xtra was previously marketed by Cox Veterinary Laboratory as an OTC drug for use in horses, and contains Omeprazole. This recall has been initiated due to information from the FDA that Gastroade Xtra must have an approved new animal drug
application to be legally marketed in the United States. Gastroade Xtra is not approved by the
FDA. In addition, some lots may be sub-potent and pose a risk of continued ulceration. As a
consequence, Cox Veterinary Laboratory has ceased all production and sales of Gastroade Xtra
and is recalling the product.
Because the FDA has not approved Gastroade Xtra, the safety and efficacy of the product has not
yet been established. To date, however, there have been no reported adverse events associated
with the use of Gastroade Xtra.
January 23, 2015 — Chester, SC — Cox Veterinary Laboratory, Inc. is
voluntarily recalling the lots of Gastroade Xtra identified below down to the consumer level
distributed nationwide. Gastroade Xtra was previously marketed by Cox Veterinary Laboratory as an OTC drug for use in horses, and contains Omeprazole. This recall has been initiated due to information from the FDA that Gastroade Xtra must have an approved new animal drug
application to be legally marketed in the United States. Gastroade Xtra is not approved by the
FDA. In addition, some lots may be sub-potent and pose a risk of continued ulceration. As a
consequence, Cox Veterinary Laboratory has ceased all production and sales of Gastroade Xtra
and is recalling the product.
Because the FDA has not approved Gastroade Xtra, the safety and efficacy of the product has not
yet been established. To date, however, there have been no reported adverse events associated
with the use of Gastroade Xtra.