← FDA ENFORCEMENT
D-0960-2023Class II

Central Admixture Pharmacy Services, Inc.

Recalling firm
Central Admixture Pharmacy Services, Inc.
Product type
Drug
Status
Terminated
Report date
2023-08-09
Distribution
Nationwide in the USA
Firm state
AZ
Product quantity
7518 bag
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

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.

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.