November 13, 2020
Zydus Pharmaceuticals USA Inc. is voluntarily recalling two lots of lansoprazole delayed-release orally disintegrating tablets because samples failed to meet dissolution specifications, according to the November 11, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall includes the following products, which were manufactured by Cadila Healthcare Limited and distributed throughout the United States:
- 100-count lansoprazole delayed-release orally disintegrating tablets, 15 mg (NDC 68382-771-77), from lot M005681 (Exp. 3/22); and
- 100-count lansoprazole delayed-release orally disintegrating tablets, 30 mg (NDC 68382-772-77), from lot M005682, (Exp. 3/22).
Zydus Pharmaceuticals initiated the recalls October 27, 2020. The FDA designated them Class II on November 10, 2020, signaling use of the recalled products could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Lansoprazole is a prescription proton-pump inhibitor that treats stomach ulcers, gastroesophageal reflux disease, and high levels of stomach acid.