Drug product
ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
D-0189-2021
Product summary
- Event
- Event 86990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,257 syringes
- Official record key
drug-enforcement:D-0189-2021
Official wording
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Code information: Lot # 1220022996, BUD 1/21/2021; 1220023017, BUD 1/20/2021; 1220023021, BUD 1/17/2021; 1220023033, BUD 1/19/2021; 1220023146, BUD 1/26/2021; 1220023189, BUD 1/27/2021 1220023242, BUD 1/25/2021; 1220023321, BUD 2/2/2021; 1220023357 BUD 2/10/2021
Distribution pattern: Product was distributed to hospitals nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility