Anticonvulsant Recalled

Deviations from Current Good Manufacturing Practice regulations have prompted American Health Packaging to recall a single lot of valproic acid oral solution. According to the October 6, 2021, US Food and Drug Administration (FDA) Enforcement Report, there is “potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.” 

The recall affects valproic acid oral solution, 500 mg/10 mL, 100 unit-dose cups (NDC 60687-262-42) per case (NDC 60687-262-56), from lot 1000082 (Exp. 6/30/22). The product was packaged and distributed by American Health Packaging, Columbus, OH, throughout the United States. 

American Health Packaging voluntarily initiated the recall September 15, 2021. The FDA designated the recall Class II on September 24, 2021. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists. 

Valproic acid is a prescription medication used to treat seizures and bipolar disorder. It is also used to prevent migraine headaches.