Drug product
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205
D-0064-2018
Product summary
- Event
- Event 78320
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 60 bag inside rigid translucent plastic case (CADD) b) 238 bag
- Official record key
drug-enforcement:D-0064-2018
Official wording
Reason: Lack Of Assurance Of Sterility.
Code information: Lots: a) 20170905@24 BUD: 12/04/2017 b) 20170901@25 BUD: 11/30/2017
Distribution pattern: Nationwide in the United States
Derived failure modes
-
Sterility assurance
Lack Of Assurance Of Sterility