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Recall Observatory FDA recall evidence

Drug product

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

D-0017-2015

June 02, 2014

Class II

Product summary

Firm
Unit Dose Solutions Inc
Event
Event 68917
Status
Terminated
Classification
Class II
Quantity
1,177 packets
Official record key
drug-enforcement:D-0017-2015

Official wording

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

Code information: Lot 204751 Exp. 04/15

Distribution pattern: PA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets