FDA Drug recall D-126-2013
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC…
- FDA Drug
- Class III
- terminated
- Published 2013-01-23
On 2013-01-23 the FDA classified a Class III recall of Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC… by Boehringer Ingelheim Roxane, citing impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-126-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-12-12 |
| Published | 2013-01-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Boehringer Ingelheim Roxane |
| Distribution | US |
Product
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Reason
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Identifiers
| code_info | Lot #160017A, Exp 04/2013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class III · 2015-10-21 · Boehringer Ingelheim Roxane - FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, O…
FDA Drug · Class III · 2015-10-21 · Boehringer Ingelheim Roxane - COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inha…
FDA Drug · Class II · 2015-08-05 · Boehringer Ingelheim Roxane - Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc
FDA Drug · Class II · 2015-06-03 · Boehringer Ingelheim Roxane - OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only
FDA Drug · Class III · 2014-08-06 · Boehringer Ingelheim Roxane
All Boehringer Ingelheim Roxane recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-126-2013%22
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