Skip to content
Recall Observatory FDA recall evidence

Drug product

Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25

D-1313-2014

April 04, 2014

Class III

Product summary

Firm
Boehringer Ingelheim Roxane Inc
Event
Event 67928
Status
Terminated
Classification
Class III
Quantity
8,304 bottles
Official record key
drug-enforcement:D-1313-2014

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 261983A Exp.11/15

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing