Drug product
Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
D-0194-2021
Product summary
- Event
- Event 86990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,614 syringes
- Official record key
drug-enforcement:D-0194-2021
Official wording
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Code information: Lot # 1220023043, BUD 2/3/2021; 1220023141, BUD 2/9/2021; 1220023429, BUD 2/18/2021 & 1220023470, BUD 2/18/2021.
Distribution pattern: Product was distributed to hospitals nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility