FDA-Drug2015-07-29Class II

Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0669-01.

Wockhardt Usa Inc.
Hazard

CGMP Deviations: Firm did not adequately investigate customer complaints.

Sold states
U.S. Nationwide including Puerto Rico.
Affected count
16,276 Bottles
Manufactured in
20 Waterview Blvd Ste 3, N/A, Parsippany, NJ, United States
Products
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0669-01.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1268-2015

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