← FDA ENFORCEMENT
D-0948-2023Class 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
3,980 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 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1

Code / lot info

Lot: 36-245576, Exp. 8/2/2023; 36-254436, 36-254442, Exp. 9/5/2023; 36-255131, Exp. 9/6/2023; 36-256045, Exp. 9/11/2023; 36-239523, Exp. 7/12/2023; 36-248987, Exp. 8/16/2023; 36-240797, Exp. 7/17/2023; 36-241979, Exp. 7/24/2023; 36-242705, Exp. 7/26/2023; 36-251733, 36-251738, 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.