← FDA ENFORCEMENT
D-0958-2023Class 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
6,784 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

EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.

Code / lot info

Lot: 36-239245, Exp. 7/10/2023; 36-241047, Exp. 7/18/2023; 36-241440, 36-241441, 36-241442, Exp. 7/20/2023; 36-242432, Exp. 7/25/2023; 36-243662, Exp. 7/30/2023; 36-246152, 36-246153, 36-246158, Exp. 8/3/2023; 36-246730, 36-246731, 36-246732, Exp. 8/6/2023; 36-247332, 36-247334, 36-247337, Exp. 8/8/2023; 36-249469, Exp. 8/17/2023; 36-249589, Exp. 8/18/2023; 36-250300, Exp. 8/23/2023; 36-251335, Exp. 8/27/2023; 36-254370, Exp. 9/4/2023.

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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.