FDA Drug recall D-1329-2016
Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceutica…
- FDA Drug
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceutica… by Pharmakon Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1329-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-20 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmakon Pharmaceuticals |
| Distribution | US |
Product
Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0938-68
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | All Sterile Compounded Products within Expiry |
|---|
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-1329-2016%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.