FDA Drug recall D-0011-2016
FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, O…
- FDA Drug
- Class III
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class III recall of FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, O… by Boehringer Ingelheim Roxane, citing CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0011-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-09-25 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Boehringer Ingelheim Roxane |
| Distribution | US |
Product
FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.
Reason
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Identifiers
| upc | 300544297318 |
|---|---|
| ndc | 0054-4297-31 |
| ndc | 0054-4297-25 |
| ndc | 0054-8297-25 |
| ndc | 0054-4299-31 |
| ndc | 0054-4299-25 |
| ndc | 0054-8299-25 |
| ndc | 0054-4301-29 |
| ndc | 0054-4301-25 |
| ndc | 0054-8301-25 |
| ndc | 0054-3298-63 |
| ndc | 0054-3294-50 |
| ndc | 0054-3294-46 |
| code_info | Lot #: 559660P, 559661P, Exp 03/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Boehringer Ingelheim Roxane
- FUROSEMIDE Tablets USP, 40 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 - 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-0011-2016%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.