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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Product Detail

Product Description Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
Recall Number D-1313-2014
Classification Class III
Code Info Lot 261983A Exp.11/15
Product Distributed Qty 8,304 bottles
Reason For Recall 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.

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