FDA’s analysis found that the chunk meat dog foods, including Evanger’s Braised Beef Chunks, Evangr’s Hand Packed Hunk of Beef, and Against the Grain Pulled Beef with Gravy were contaminated with pentobarbital, a drug used for euthanizing animals. There is no residue tolerance for this drug, so the products were adulterated. FDA inspectors also found pentobarbital in other products with different lot codes and best by dates.
The company did not have documentation showing that the supplier that supplied the contaminated beef material was the only one selling the material that was made into their products. In addition, the company stated that “if any amount of pentobarbital were to be found in any of your ground loaf products, it would be in an amount that a laboratory would deem as being within the possibility of error and well within the range that FDA had previously deemed not be a health or safety concern in pet foods.”
FDA responded by stating, “FDA does not agree with your assessment that the process of grinding will dilute any pentobarbital present in the loaf products to non-detectable or safe levels. The agency notes that there is no tolerance level for pentobarbital in pet food.”
The company also said they would conduct “random testing” of finished products for pentobarbital. But the FDA said that random finished product testing was not adequate, as “pentobarbital contamination is not homogeneous throughout all units in a lot. Therefore, random testing of finished product may not be representative of all units of your products. Furthermore, finished product testing cannot mitigate the risk of pentobarbital in your raw material.”
Evanger’s was using letters of guarantee that the products sold to them by suppliers were safe. But the FDA did not think that was adequate, and said the company should conduct site audits and reviews of the supplier’s procedures to make sure that the beef products were safe.
Evanger’s then said they wanted to donate the recalled products to an animal shelter. The FDA rejected that notion, stating that “FDA does not find it acceptable to donate any recalled products and instead recommends destruction of all remaining units.”
Evanger’s must reply in writing within fifteen working days of the letter, which was dated June 29, 2017, and note the specific steps they have taken to correct the violations. Evanger’s must also pay for re-inspection costs incurred by the FDA.
