D-0005-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 11, 2023
- Initiation Date
- September 21, 2023
- Termination Date
- March 19, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,384 10 mL syringes
Product Description
PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
Reason for Recall
Lack of assurance of sterility:
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 17-275231, 17-275232, Exp. 10/2/2023; 17-275563, 17-275567, 17-275573, 17-275580, Exp. 10/8/2023; 17-275767, 17-275784, Exp. 10/10/2023;