D-1314-2014 Class III Terminated
FDA drug recall D-1314-2014 was initiated by Boehringer Ingelheim Roxane Inc on April 4, 2014 and is designated Class III. 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. The recall status is terminated (terminated April 1, 2015). Affected quantity: 98,560 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 14, 2014
- Initiation Date
- April 4, 2014
- Termination Date
- April 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98,560 bottles
Product Description
Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11
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.
Distribution Pattern
Nationwide
Code Information
Lot 261997A Exp 02/16; 262214V, 359283V Exp. 05/16