MAGNESIUM Sulfate added to 100 mL 0 — Class II drug recall D-0878-2017
Terminated recall by SCA Pharmaceuticals, reported 2017-06-07, distributed nationwide. Lack of assurance of sterility: Product bags leaking at seam.
| Recall number | D-0878-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, Little Rock, AR, United States |
| Recall initiated | 2017-05-18 |
| Classified | 2017-05-31 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2018-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 40 bags |
| Reason classes | sterility, packaging |
| NDC | 70004-0737-32 |
| Expiration dates | 2017-08-07 |
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 for recall
Lack of assurance of sterility: Product bags leaking at seam.
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-0878-2017. 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.