Ketamine 50 mg/5 mL in 0 — Class II drug recall D-1843-2019
Terminated recall by SCA Pharmaceuticals, LLC, reported 2019-08-28, distributed nationwide. Lack of Assurance of Sterility.
| Recall number | D-1843-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, LLC, Windsor, CT, United States |
| Recall initiated | 2019-08-16 |
| Classified | 2019-08-26 |
| Reported by FDA | 2019-08-28 |
| Terminated | 2019-10-15 |
| Distributed | Nationwide (US) |
| Quantity | 922 syringes |
| Reason classes | sterility |
| NDC | 70004-0430-09 |
| Lot numbers | 1219010961 |
| Expiration dates | 2019-10-24 |
Product
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
Reason for recall
Lack of Assurance of Sterility.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1843-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.