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Recall Observatory FDA recall evidence

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

April 04, 2014

Class III

Product summary

Firm
Boehringer Ingelheim Roxane Inc
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

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing