FDA recall D-0017-2015

Unit Dose Solutions Inc · Class II · drug

Product

Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808

Reason for recall

Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium

Distribution

PA

Key facts

Status
Terminated
Initiation date
2014-06-02
Report date
2014-10-22
Termination date
2014-10-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0017-2015