HYDROmorphone HCl 6 mg/30mL in 0 — Class II drug recall D-0195-2021
Terminated recall by SCA Pharmaceuticals, reported 2021-01-13, distributed nationwide. Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
| Recall number | D-0195-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, Windsor, CT, United States |
| Recall initiated | 2020-12-17 |
| Classified | 2021-01-07 |
| Reported by FDA | 2021-01-13 |
| Terminated | 2021-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 3,092 syringes |
| Reason classes | sterility |
| Lot numbers | 1220023171, 1220023241, 1220023282, 1220023313, 1220023442, 1220023446, 1220023532, 1220023650, 1220023727 |
| Expiration dates | 2021-01-25, 2021-01-26, 2021-02-01, 2021-02-07, 2021-02-08, 2021-02-11, 2021-02-14 |
Product
HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
Reason for recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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-0195-2021. 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.