The FDA issued a warning letter to NuCare Pharmaceuticals in Orange, California for failing to fix drug listing deficiencies in the agency’s database.
More than 200 of the drugmaker’s product listing files from August 2017 until the present had many instances of noncompliance, the agency said. It issued two deficiency letters in August 2017 and another in May 2018, but many incorrect listings remained.
The FDA cited 11 violations for products ranging from permethrin, an anti-parasite insecticide, to the tetracycline antibiotic doxycycline and the muscle relaxer carisoprodol. For example, multiple instances of incorrect carton labels went unresolved, such as the company’s permethrin listing, which contained the carton label image for a different product.