← FDA ENFORCEMENT
D-1111-2023Class II

Central Admixture Pharmacy Services, Inc.

Recalling firm
Central Admixture Pharmacy Services, Inc.
Product type
Drug
Status
Terminated
Report date
2023-09-06
Distribution
Nationwide in the USA
Firm state
AZ
Product quantity
100 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Product description

Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1

Code / lot info

Lot# 36-262881, Exp 8/27/2023.

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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.