FDA Drug recall D-0055-2017
ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 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 ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 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-0055-2017 |
| 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
ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3330.
Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Identifiers
| code_info | Lot Numbers: 15118003M, 15119077M, 15121002M, 15125019M, 15126067M, 15132022M, 15132038M, 15134043M, 15139009M, 1514000…Lot Numbers: 15118003M, 15119077M, 15121002M, 15125019M, 15126067M, 15132022M, 15132038M, 15134043M, 15139009M, 15140006M, 15141004M, 15141065M, 15148045M, 15148070M, 151730156M, 151890125M, 151890208M, 151900010M, 151900125M, 151930044M, 151940270M, 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-0055-2017%22
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