PlainRecalls
FDA Drug Moderate Class II Terminated

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.