FDA-Drug2015-07-29Class II
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.
Wockhardt Usa Inc.
Hazard
CGMP Deviations: Firm did not adequately investigate customer complaints.
Sold states
U.S. Nationwide including Puerto Rico.
Affected count
A) 36,213 Bottles and B) 12,824 Bottles.
Manufactured in
20 Waterview Blvd Ste 3, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1262-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief