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.
Reported: July 29, 2015 Initiated: April 22, 2015 #D-1247-2015
Product Description
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.
Details
- Recalling Firm
- Wockhardt Usa Inc.
- Units Affected
- 37,791 Bottles
- Distribution
- U.S. Nationwide including Puerto Rico.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Wockhardt Usa Inc.. Units affected: 37,791 Bottles.
Why was this product recalled? ▼
CGMP Deviations: Firm did not adequately investigate customer complaints.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 29, 2015. Severity: Moderate. Recall number: D-1247-2015.
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