FDA Drug Class II — Moderate

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

Hazard

Lack of assurance of sterility: Product bags leaking at seam.

Products

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 Pharm
Brand
SCA Pharmaceuticals
UPC
LOT # 20170509@29, Use By: 08/07/17

Units Affected

40 bags