Recalls / Class II
Class IID-041-2013
Product
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
- Affected lot / code info
- Batch Number ZPSB11054-A Exp. 05/13
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
Recalling firm
- Firm
- Aurobindo Pharma LTD
- Notification channel
- FAX
- Type
- Voluntary: Firm initiated
- Address
- Unit VII, Formulation Plant, Survey 411, 425, 434-435, 458, Plot S1, Mehbubnagar, N/A N/A, India
Distribution
- Quantity
- 23,616 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-03-09
- FDA classified
- 2012-11-06
- Posted by FDA
- 2012-11-14
- Terminated
- 2013-11-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-041-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.