Home / Recalls / Sandoz Incorporated / D-383-2014

D-383-2014 Class II Terminated

Recalled by Sandoz Incorporated — Broomfield, CO

Recall Details

Product Type: Drugs
Report Date: January 1, 2014
Initiation Date: October 22, 2013
Termination Date: July 10, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12,521 bottles

Product Description

Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01

Reason for Recall

Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin

Distribution Pattern

Nationwide

Code Information

Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14

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