Zolpidem Tartrate Tablets recalled over manufacturing violations
- Recall date
- April 22, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Wockhardt Usa Inc. recalls Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limit…
- Recall number
- D-1247-2015
- FDA classification
- Class II
- Brand / firm
- Wockhardt Usa Inc.
- Sold / distributed
- U.S. Nationwide including Puerto Rico.
Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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.
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