Status
Terminated
Drug Enforcement D-041-2013
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
Classification
Class II
Report Date
November 14, 2012
Termination Date
November 21, 2013
Product Information
- 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
- Product quantity
- 23,616 bottles
- 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
- Recall initiation reason
- —
- Initial firm notification
- FAX
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Aurobindo Pharma LTD
- Address
-
Unit VII, Formulation Plant, Survey 411, 425, 434-435, 458, Plot S1
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-041-2013
- Event ID
- 62113
- Recall initiation date
- March 9, 2012
- Center classification date
- November 6, 2012
- Code info
- Batch Number ZPSB11054-A Exp. 05/13
- More code info
- —