FDAFDA · Food and drugs·Recall number D-126-2013
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Published January 23, 2013 · Recall initiated: December 12, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Distributor
- Nationwide
- Lot
- Lot #160017A, Exp 04/2013.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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