D-0194-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 13, 2021
- Initiation Date
- December 17, 2020
- Termination Date
- November 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,614 syringes
Product Description
Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Distribution Pattern
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023043, BUD 2/3/2021; 1220023141, BUD 2/9/2021; 1220023429, BUD 2/18/2021 & 1220023470, BUD 2/18/2021.