FDA recall D-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

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

Nationwide

Key facts

Status

Terminated

Initiation date

2012-03-09

Report date

2012-11-14

Termination date

2013-11-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mehbubnagar, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-041-2013