← FDA ENFORCEMENT
D-0970-2023Class 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
5,588 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 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6078-1

Code / lot info

Lot: 36-239526, Exp. 7/12/2023; 36-239993, Exp. 7/13/2023; 36-240796, Exp. 7/17/2023; 36-241982, Exp. 7/24/2023; 36-242696, Exp. 7/26/2023; 36-243161, Exp. 7/27/2023; 36-243954, Exp. 7/31/2023; 36-245534, Exp. 8/2/2023; 36-247885, Exp. 8/10/2023; 36-248977, 36-249137, Exp. 8/16/2023; 36-251052, Exp. 8/24/2023; 36-251705, 36-251706, Exp. 8/29/2023; 36-252190, Exp. 8/31/2023; 36-255490, 36-255492, 36-255494, Exp. 9/7/2023.

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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.