D-0216-2021 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
- 3152 syringes
Product Description
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
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 # 1220023003, BUD 12/22/2020; 1220023057, BUD 12/25/2020; 1220023104, BUD 12/25/2020; 1220023144, BUD 12/27/2020; 1220023168, BUD 12/27/2020; 1220023222, BUD 12/29/2020; 1220023240, BUD 12/28/2020; 1220023284, BUD 1/1/2021; 1220023456, BUD 1/8/2021; 1220023474, BUD 1/4/2021; 1220023530, BUD 1/8/2021 & 1220023542, BUD 1/9/2021.