D-0204-2021 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
- 23,029 syringes
Product Description
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012
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 # 1220022957, BUD 1/20/2021; 1220022993, BUD 1/21/2021; 1220023020, BUD 1/14/2021; 1220023037, BUD 1/19/2021; 1220023038, BUD 1/20/2021; 1220023074, 1/24/2021; 1220023103, BUD 1/24/2021; 1220023160, BUD 1/26/2021; 1220023180, BUD 1/27/2021; 1220023183, BUD 1/27/2021; 1220023216, BUD 1/28/2021; 1220023267, BUD 2/1/2021; 1220023272, BUD 1/3/2021; 1220023344, BUD 2/10/2021; 1220023387, BUD 2/9/2021; 1220023475,BUD 2/4/2021; 1220023479, BUD 2/4/2021; 1220023564, BUD 2/9/2021; 1220023565, BUD 2/9/2021; 1220023587, BUD 2/10/2021 & 1220023624, BUD 2/11/2021.