← FDA ENFORCEMENT
D-0979-2023Class 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
5,834 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

heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7023-1

Code / lot info

Lot: 36-246161, Exp. 7/14/2023; 36-247002, 36-247006, 36-247007, Exp. 7/18/2023; 36-247673, 36-247674, Exp. 7/20/2023; 36-247832, 36-247833, 36-247835, 36-247836, Exp. 7/21/2023; 36-248991, Exp. 7/27/2023; 36-249593, Exp. 7/29/2023; 36-250046, Exp. 8/2/2023; 36-251444, 36-251445, 36-251446, 36-251447, Exp. 8/8/2023; 36-251968, Exp. 8/10/2023; 36-254379, 36-254380, Exp. 8/15/2023; 36-254684, Exp. 8/16/2023.

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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.