Drug product
MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-905-10
D-0936-2018
Product summary
- Event
- Event 80307
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 bags
- Official record key
drug-enforcement:D-0936-2018
Official wording
Reason: Lack of Assurance of Sterility: Potential leakage of bags.
Code information: Lot # 5/1/18 0501 548-90510P, BUD 7/30/2018.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility