Class II · Moderate risk Completed
Zolpidem Tartrate Extended-Release Tablets
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Zolpidem Tartrate Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
What was recalled
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.
- Recalling firm
- Wockhardt Usa Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1262-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Zolpidem recalls
See all
Class II · Moderate risk Completed
Zolpidem Tartrate Extended-Release Tablets
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Terminated
Zolpidem Tartrate Sublingual Tablet 3.5 Mg 30 Unit Dose Pouches
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk Terminated
Intermezzo
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Intermezzo
Reason Failed dissolution specifications
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