← FDA ENFORCEMENT
D-0951-2023Class 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
2,260 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 dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1

Code / lot info

Lot: 36-243946, 36-243947, 36-243948, 36-243949, Exp. 7/11/2023; 36-255120, Exp. 8/17/2023; 36-246829, 36-246831, 36-246832, Exp. 7/18/2023; 36-255961, Exp. 8/21/2023; 36-256896, Exp. 8/25/2023.

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See all Environmental Monitoring recalls →

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.