← FDA ENFORCEMENT
D-0953-2023Class 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
3,699 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

dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1

Code / lot info

Lot: 36-244893, 36-244894, 36-244895, Exp. 7/12/2023; 36-246428, 36-246429, 36-246647, 36-246648, Exp. 7/14/2023; 36-254364, 36-254365, 36-254366, 36-254367, 36-254368, Exp. 8/15/2023; 36-246824, 36-246825, 36-246828, Exp. 7/18/2023; 36-256157, Exp. 8/21/2023; 36-256890, Exp. 8/25/2023.

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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.