FDA Drug recall D-1085-2015
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
- completed
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc by Boehringer Ingelheim Roxane, citing subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1085-2015 |
| Classification | Class II |
| Status | completed |
| Initiated | 2015-04-02 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Boehringer Ingelheim Roxane |
| Distribution | US |
Product
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25
Reason
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Identifiers
| ndc | 0054-0140-25 |
|---|---|
| ndc | 0054-0141-20 |
| ndc | 0054-0141-25 |
| ndc | 0054-0142-25 |
| code_info | a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: completed.
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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 - 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 - Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41
FDA Drug · Class II · 2014-07-16 · Boehringer Ingelheim Roxane
All Boehringer Ingelheim Roxane recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1085-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.