FDA Drug recall D-1323-2016
Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC…
- FDA Drug
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC… by Pharmakon Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1323-2016 |
| 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 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0925-41
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-1323-2016%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.