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
Reported: June 7, 2017 Initiated: May 18, 2017 #D-0878-2017
Product Description
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.
Details
- Recalling Firm
- SCA Pharmaceuticals
- Units Affected
- 40 bags
- Distribution
- Nationwide in the USA
- Location
- Little Rock, AR
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SCA Pharmaceuticals. Units affected: 40 bags.
Why was this product recalled? ▼
Lack of assurance of sterility: Product bags leaking at seam.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 7, 2017. Severity: Moderate. Recall number: D-0878-2017.
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