OTC Pain Reliever Recalled Over Contamination Concern

Failure to properly investigate failed microbial testing has prompted Plastikon Healthcare to recall a single lot of acetaminophen oral solution labeled for Major Pharmaceuticals, according to the May 25, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall is for acetaminophen oral solution, 650 mg/20.3 mL, packaged in trays of 10 cups, 10 trays per carton (NDC 0904-6820-76), from lot 20040A (Exp. 5/22). Major Pharmaceuticals distributed the medication to hospitals, nursing homes, and clinics throughout the United States.

Plastikon Healthcare voluntarily initiated the recall March 24, 2022. The FDA designated the recall Class II on May 13, 2022. 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.

In a March 24, 2022, statement announcing the recall, Plastikon Healthcare advised anyone with the recalled product to immediately quarantine it.

“Return all quarantined product to the place of purchase,” the statement directed. “For clinics, hospitals, or health care providers that have dispensed product to patients, please notify patients regarding the recall.”

Acetaminophen 650 mg/20.3 mL is an over-the-counter medication indicated for temporarily relief of minor aches and pains and temporarily reduction of fever.