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.
Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
What was recalled
Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India
- Recalling firm
- Aurobindo Pharma LTD
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-041-2013
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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