Perindopril Erbumine Tablets recall: Impurity Out of Spec
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC…
Why was Perindopril Erbumine Tablets recalled?
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #160017A, Exp 04/2013.
- Product
- Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC…
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Quantity
- 3,553 bottles
- Distribution
- Nationwide
- Recall date
- January 23, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)