Drug product
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC: 70004-0100-59; b) NDC: 70004-100-58.
D-0999-2017
Product summary
- Event
- Event 77777
- Status
- Terminated
- Classification
- Class II
- Quantity
- 220 bags
- Official record key
drug-enforcement:D-0999-2017
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: Lots: a) 20170707@34, BUD:10/5/2017; 20170710@21, BUD: 10/8/2017; b) 20170706@44, BUD: 10/4/2017
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility