FDA recall D-1247-2015

Product

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.

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Distribution

U.S. Nationwide including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2015-04-22

Report date

2015-07-29

Termination date

2018-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

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