Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Reported: January 23, 2013 Initiated: December 12, 2012 #D-126-2013
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.
Details
- Recalling Firm
- Boehringer Ingelheim Roxane Inc
- Units Affected
- 3,553 bottles
- Distribution
- Nationwide
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.. Recalled by Boehringer Ingelheim Roxane Inc. Units affected: 3,553 bottles.
Why was this product recalled? ▼
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 23, 2013. Severity: Low. Recall number: D-126-2013.
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