Pain Reliever Recalled

More than 300,000 unit dose cups of acetaminophen oral suspension marketed for hospital use are being recalled by Precision Dose Inc due to a contaminated ingredient, according to the November 17, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were distributed throughout the United States:

• acetaminophen oral suspension, 160 mg/5 mL (individual cup NDC 68094-231-59), packaged in 30-count (NDC 68094-231-62) and 100-count (NDC 68094-231-61) cases, hospital use only, from lot 503670, and
• acetaminophen oral suspension, 325 mg/10.15 mL (individual cup NDC 68094-330-59), packaged in 30-count (NDC 68094-330-62) and 100-count (NDC 68094-330-61) cases, hospital use only, from lots 503679, 503693, and 503715.

Precision Dose Inc voluntarily initiated the recall November 1, 2021. On November 5, 2021, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Acetaminophen is an over-the-counter medication used to reduce fever and relieve minor aches and pains.