FDA Drug recall D-0591-2016
Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2016-02-03
On 2016-02-03 the FDA classified a Class II recall of Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc by Pharmakon Pharmaceuticals, citing stability data does not support expiry.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0591-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-19 |
| Published | 2016-02-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmakon Pharmaceuticals |
| Distribution | US |
Product
Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Reason
Stability data does not support expiry.
Identifiers
| code_info | All lots with expiration dates up to 11/17/2015 |
|---|
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-0591-2016%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.