Recalls / Class III
Class IIID-1313-2014
Product
Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
- Affected lot / code info
- Lot 261983A Exp.11/15
Why it was 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.
Recalling firm
- Firm
- Boehringer Ingelheim Roxane Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 8,304 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-04-04
- FDA classified
- 2014-05-06
- Posted by FDA
- 2014-05-14
- Terminated
- 2015-04-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1313-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.