December 23, 2020
Zydus Pharmaceuticals (USA) Inc. is recalling five lots of lansoprazole delayed-release tablets because samples failed to meet dissolution specifications during routine testing, according to the December 23, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were manufactured by Cadila Healthcare Limited and distributed throughout the United States:
- lansoprazole delayed-release orally disintegrating tablets, 15 mg, 100 tablets (10 blister packs in one carton, NDC 68382-771-77), from lots M915744 (Exp. 10/21) and M904770 (2/21); and
- lansoprazole delayed-release orally disintegrating tablets, 30 mg, 100 tablets (10 blister packs in one carton, NDC 68382-772-77), from lots M900412 (Exp. 12/20), M904772 (Exp. 2/21), and M915745 (Exp. 10/21).
Zydus Pharmaceuticals voluntarily initiated the recall December 3, 2020. The FDA designated the recall Class II on December 11, 2020, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Prescription-strength lansoprazole is used to treat stomach and esophagus problems such as gastroesophageal reflux disease (GERD) and ulcers.