FDA Drug recall D-1441-2016
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
- FDA Drug
- Class III
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class III recall of Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41 by West Ward Columbus, citing failed Impurities/Degradation Specification; 9 month stability.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1441-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-05-19 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | West Ward Columbus |
| Distribution | US |
Product
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
Reason
Failed Impurities/Degradation Specification; 9 month stability
Identifiers
| ndc | 0054-0390-41 |
|---|---|
| ndc | 0054-0390-63 |
| code_info | Lot #560185A; Exp. 6/30/2017 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1441-2016%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.