FDA orders recall of sterile veterinary drug products from 2 labs
The Food and Drug Administration has ordered the recall of all sterile veterinary drug products of Belman Laboratories and Enson Laboratories Inc. after an inspection of their facilities showed “significant critical and major deficiencies.”
The FDA issued advisories on March 30, 2016 informing healthcare professionals and the general public of the recall.
For Belman Laboratories, the sterile veterinary drug products covered by the recall were those manufactured from August 10, 2015 to December 15, 2015.
In FDA Advisory No. 2016-30, the FDA said the recall of the Belman Laboratories sterile veterinary products was due to its failure to comply with existing standard.
“Belman Laboratories has been ordered to discontinue distributing and offering these products for sale to the consumers,” the advisory said. “The affected products present safety risk and potential adverse health consequences.”
The sterile veterinary drug products being recalled from Enson Laboratories cover those manufactured from January 1, 2015 to December 18, 2015. Its products are being recalled after an inspection of its facility also showed significant critical and major deficiencies.
The FDA has advised the public against the distribution and sale of the products from the two laboratories. It also advised against the use of the products on animals.
The FDA’s field officers have been ordered to monitor the products in the market. Should they find it for sale in establishments, they are ordered to seal the stocks and ask the establishment to return the stocks to representatives of the laboratories for proper destruction. (By: Eileen A. Mencias)