Drug product
Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
D-0894-2018
Product summary
- Event
- Event 80303
- Status
- Terminated
- Classification
- Class II
- Quantity
- 440 syringes
- Official record key
drug-enforcement:D-0894-2018
Official wording
Reason: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information: Lot # 20180323@44, Exp 06/21/2018
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility