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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Detail

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
Recall Number D-383-2014
Classification Class II
Code Info Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
Product Distributed Qty 12,521 bottles
Reason For Recall Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin

Event Detail

Event Id 66531
Product Type Drugs
Status Ongoing
Recalling Firm Sandoz Incorporated
City Broomfield
State CO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide