D-0960-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2023
- Initiation Date
- July 14, 2023
- Termination Date
- March 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7518 bag
Product Description
PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 36-239333, Exp. 7/11/2023; 36-240005, Exp. 7/13/2023; 36-240800, Exp. 7/17/2023; 36-241139, 36-241140, Exp. 7/19/2023; 36-241913, Exp.7/23/2023; 36-242557, 36-242560, Exp. 7/25/2023; 36-244880, 36-244883, 36-244884, 36-244885, Exp. 8/1/2023; 36-246717, 36-246718, 36-246719, 36-246720, Exp.8/6/2023; 36-247598, 36-247599, Exp. 8/9/2023; 36-247828, 36-247829, 36-247830, 36-247831, Exp. 8/10/2023; 36-249233, 36-249234, 36-249235, 36-249344, Exp. 8/17/2023; 36-255964, Exp. 9/10/2023