FDA Drug recall D-0878-2017
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Sin…
- FDA Drug
- Class II
- terminated
- Published 2017-06-07
On 2017-06-07 the FDA classified a Class II recall of MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Sin… 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-0878-2017 |
| 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
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32
Reason
Lack of assurance of sterility: Product bags leaking at seam.
Identifiers
| code_info | LOT # 20170509@29, Use By: 08/07/17 |
|---|
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-0878-2017%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.