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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Event Detail

Event ID 67928
Product Type Drugs
Status Ongoing
Recalling Firm Boehringer Ingelheim Roxane Inc
City Columbus
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-04
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11 Lot 261997A Exp 02/16; 262214V, 359283V Exp. 05/16 Class III Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months. 98,560 bottles D-1314-2014
Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25 Lot 261983A Exp.11/15 Class III Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months. 8,304 bottles D-1313-2014
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