D-0415-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 3, 2024
- Initiation Date
- November 9, 2023
- Termination Date
- August 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,198 syringes; expanded 1,289 syringes
Product Description
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 1223045053 Exp 11/15/23; 1223046179 Exp 12/28/23; 1223047477 Exp 02/16/24; 1223047602 Exp 02/22/24; 1223047971 Exp 03/14/24; 1223048269 Exp 03/27/24 Expanded lot#: 1223048181, exp. date 03/22/2024