Drug product
MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.
D-1003-2017
Product summary
- Event
- Event 77777
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 bags
- Official record key
drug-enforcement:D-1003-2017
Official wording
Reason: Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Code information: Lot: 20170710@54, BUD: 10/8/2017
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility