Recalls / Class III
Class IIID-126-2013
Product
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
- Affected lot / code info
- Lot #160017A, Exp 04/2013.
Why it was recalled
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
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
- 3,553 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-12-12
- FDA classified
- 2013-01-16
- Posted by FDA
- 2013-01-23
- Terminated
- 2014-06-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-126-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.