Ulcer Medication Recalled

Aurolife Pharma LLC is recalling 7344 bottles of glycopyrrolate tablets after samples failed to meet impurity/degradation specifications, according to the December 28, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 1-mg glycopyrrolate tablets, 100-count bottles (NDC 13107-014-01), from lots 01422002A1 (Exp. 12/23) and 01421078A3 (Exp. 9/23). Aurobindo Pharma USA Inc., East Windsor, New Jersey, distributed the tablets throughout the United States and in Puerto Rico.

The firm voluntarily initiated the recall December 16, 2022, and the FDA designated the recall Class II on December 22, 2022. Use of medication under Class II recall could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm, according to the FDA.

Glycopyrrolate is a prescription medication used in the treatment of peptic ulcer.