FDA Drug recall D-0875-2017
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Do…
- FDA Drug
- Class II
- terminated
- Published 2017-06-07
On 2017-06-07 the FDA classified a Class II recall of HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Do… by Sca Pharmaceuticals, citing lack of assurance of sterility: Product bags leaking at seam.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0875-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-18 |
| Published | 2017-06-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sca Pharmaceuticals |
| Distribution | US |
Product
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
Reason
Lack of assurance of sterility: Product bags leaking at seam.
Identifiers
| code_info | LOT # 20170505@23, 20170505@28, Use By: 08/03/17 |
|---|
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-0875-2017%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.