FDA-Drug2015-07-29Class II

Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01.

Wockhardt Usa Inc.
Hazard

CGMP Deviations: Firm did not adequately investigate customer complaints.

Sold states
U.S. Nationwide including Puerto Rico.
Affected count
37,791 Bottles
Manufactured in
20 Waterview Blvd Ste 3, N/A, Parsippany, NJ, United States
Products
Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1247-2015

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