← FDA ENFORCEMENT
D-0963-2023Class 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
9,432 bags
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, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1.

Code / lot info

Lot: 36-240803, Exp. 7/17/2023; 36-241149, Exp. 7/19/2023; 36-241912, Exp. 7/23/2023; 36-243527, 36-243529, Exp. 7/30/2023; 36-244889, 36-244890, 36-244891, Exp. 8/1/2023; 36-246709, 36-246710, 36-246711, 36-246712, Exp. 8/6/2023; 36-247014, Exp. 8/7/2023; 36-247611, 36-247614, 36-247616, 36-247629, 36-247631, 36-247640, Exp. 8/9/2023; 36-248282, 36-248283, 36-248285, Exp. 8/13/2023; 36-249217, 36-249219, 36-249221, 36-249223, Exp. 8/17/2023; 36-251389, 36-251390, 36-251391, Exp. 8/27/2023; 36-251512, Exp. 8/28/2023; 36-251971, 36-251973, Exp. 8/30/2023; 36-252468, Exp. 9/3/2023

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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.