Recall: D-0145-2021

Class II - Potentially Harmful

Class IIClassification

2020-12-03Initiated

TerminatedStatus

Zydus Pharmaceuticals (USA) InFirm

Product

Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77

Reason

Failed Dissolution Specifications

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.