PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: May 14, 2014 Initiated: April 4, 2014 #D-1313-2014

Product Description

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

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.

Details

Units Affected
8,304 bottles
Distribution
Nationwide
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25. Recalled by Boehringer Ingelheim Roxane Inc. Units affected: 8,304 bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 14, 2014. Severity: Low. Recall number: D-1313-2014.