Drug product
Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11
D-1314-2014
Product summary
- Event
- Event 67928
- Status
- Terminated
- Classification
- Class III
- Quantity
- 98,560 bottles
- Official record key
drug-enforcement:D-1314-2014
Official wording
Reason: 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.
Code information: Lot 261997A Exp 02/16; 262214V, 359283V Exp. 05/16
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing