Wockhardt Usa Inc. recalls Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bo
Recalled July 29, 2015 · FDA recall D-1262-2015 · Wockhardt Usa
Hazard
CGMP Deviations: Firm did not adequately investigate customer complaints. · FDA Class II
Units
A) 36,213 Bottles and B) 12,824 Bottles.
Sold at
U.S. Nationwide including Puerto Rico.
Description
CGMP Deviations: Firm did not adequately investigate customer complaints.
Product
Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Manufacturer(s)
Wockhardt Usa Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →