USA – FDA slams repackager for unsupported drug expiration dates

A Massachusetts drug repackager has been cited by the FDA for failing to provide cleaning protocols for equipment that is used for packaging multiple products.

The FDA has slapped around a U.S. drug repackager, saying in a warning letter that its storage processes and equipment cleaning are not up to expectations.

The warning letter for Worcester, Massachusetts-based Lohxa criticized the plant for giving lots of repackaged unit dose drugs, including pneumonia treatment atovaquone oral suspension, expiration dates of 12 months from repackaging but had no data to support the dates.

The company claimed to have data to support a six-month expiration date, but the FDA said it never made the information available…