D-041-2013 Class II Terminated
FDA drug recall D-041-2013 was initiated by Aurobindo Pharma LTD on March 9, 2012 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated November 21, 2013). Affected quantity: 23,616 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 14, 2012
- Initiation Date
- March 9, 2012
- Termination Date
- November 21, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,616 bottles
Product Description
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
Reason for Recall
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
Distribution Pattern
Nationwide
Code Information
Batch Number ZPSB11054-A Exp. 05/13