← FDA ENFORCEMENT
D-0950-2023Class 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
4824 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

vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1

Code / lot info

Lot: 36-245562, Exp. 8/2/2023; 36-254425, Exp. 9/5/2023; 36-255129, Exp. 9/6/2023; 36-238965, Exp. 7/10/2023; 36-256041, Exp. 9/11/2023; 36-241129, 36-241130, Exp. 7/19/2023; 36-241438, Exp. 7/20/2023; 36-242703, Exp. 7/26/2023; 36-243163, 36-243164, Exp. 7/27/2023; 36-251724, 36-251727, Exp. 8/29/2023.

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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.