FDA Drug recall D-0196-2021
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) an…
- FDA Drug
- Class II
- terminated
- Published 2021-01-13
On 2021-01-13 the FDA classified a Class II recall of HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) an… by Sca Pharmaceuticals, citing lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0196-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-17 |
| Published | 2021-01-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sca Pharmaceuticals |
| Distribution | US |
Product
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Identifiers
| code_info | a) Lot # 1220022964, BUD 1/19/2021; 1220023280, BUD 2/1/2021 & 1220023623, BUD 2/10/2021. b) Lot # 1220023347, BUD 2/17/2021. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0196-2021%22
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