Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-140-00.

Recall Number: D-1251-2015

Firm: Wockhardt Usa Inc.

Classification: Class II

Status: Terminated

Report Date: 20150729

Initiation Date: 20150422

Termination Date: 20180509

Reason for Recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Product Description

Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-140-00.