Drug product
MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-10
D-0938-2018
Product summary
- Event
- Event 80307
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1500 bags
- Official record key
drug-enforcement:D-0938-2018
Official wording
Reason: Lack of Assurance of Sterility: Potential leakage of bags.
Code information: Lot #: 5/15/18 6413 24110P, BUD; 9/12/2018; 5/16/18 0744 24110P, BUD 9/13/2018.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility