CLASS III Drug recall · Reported 23 Jan 2013 · FDA Enforcement Report
Perindopril Erbumine Tablets, 8mg recalled
Boehringer Ingelheim Roxane is recalling Perindopril Erbumine Tablets, 8mg per, distributed nationwide in the US. The recall was initiated on 12 Dec 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-126-2013
- FDA event ID
- 63952
- Recalling firm
- Boehringer Ingelheim Roxane, Columbus, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Dec 2012
- FDA classified
- 16 Jan 2013
- Reported
- 23 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 12 Dec 2012 | Recall initiated by company | |
| 16 Jan 2013 | Classified by FDA | +35 days |
| 23 Jan 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Which lots are affected?
Lot #160017A, Exp 04/2013.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Boehringer Ingelheim Roxane
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|---|---|---|---|---|---|
| Drug | CLASS III | Furosemide Tablets USP, 40 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
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