Drug 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
D-041-2013
Product summary
- Event
- Event 62113
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,616 bottles
- Official record key
drug-enforcement:D-041-2013
Official wording
Reason: 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
Code information: Batch Number ZPSB11054-A Exp. 05/13
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets