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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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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
Distribution Pattern Nationwide

Product Detail

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