Opioid Analgesic Recalled

Akorn Inc is recalling 10,836 bottles of morphine sulfate oral solution because of missing labels, according to the January 19, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects morphine sulfate oral solution, 100 mg/5 mL (20 mg/mL), 30-mL bottles (NDC 50383-965-30), from lot 375153 (Exp. 10/31/22). The packager was Hi-Tech Pharmacal Co Inc, and the bottles were distributed throughout the United States.

Akorn voluntarily initiated the recall December 3, 2021. On January 13, 2022, the FDA designated the recall Class III. Under the recall classification, use of the affected product is not likely to cause harm.

Morphine sulfate oral solution is a schedule II narcotic indicated for the relief of acute and chronic pain in opioid-tolerant adult patients.