FDA Drug recall D-0089-2017
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Produ…
- FDA Drug
- Class II
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class II recall of rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Produ… by Pharmedium Services, citing stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0089-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-17 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmedium Services |
| Distribution | US |
Product
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.
Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Identifiers
| code_info | Lot Numbers: 151120168M, 151120169M, 15112027M, 15112096M, 15113021M, 15113080M, 15113081M, 15113082M, 15113083M, 15113…Lot Numbers: 151120168M, 151120169M, 15112027M, 15112096M, 15113021M, 15113080M, 15113081M, 15113082M, 15113083M, 15113084M, 15113085M, 15113086M, 15113087M, 15113088M, Exp between 07/15/15-10/12/15 |
|---|
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-0089-2017%22
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