D-126-2013 Class III Terminated
FDA drug recall D-126-2013 was initiated by Boehringer Ingelheim Roxane Inc on December 12, 2012 and is designated Class III. Reason for recall: Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite. The recall status is terminated (terminated June 16, 2014). Affected quantity: 3,553 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 23, 2013
- Initiation Date
- December 12, 2012
- Termination Date
- June 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,553 bottles
Product Description
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Reason for Recall
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Distribution Pattern
Nationwide
Code Information
Lot #160017A, Exp 04/2013.