Reported Jan 23, 2013 · Terminated
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc.,…
Boehringer Ingelheim Roxane Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boehringer Ingelheim Roxane Inc · 1809 Wilson Rd · Columbus, OH · 43228-9579
Is this the product you have?
- Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
- Lot codes and dates
Lot #160017AExp 04/2013
- Amount recalled
- 3,553 bottles
Where it was sold
- Nationwide
Why it was recalled
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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