← FDA ENFORCEMENT
D-1054-2023Class 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
CA
Product quantity
2,082 syringes
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

fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3

Code / lot info

Lot: 17-271133, 17-271155, Exp. 7/25/2023; 17-271568, 17-271569, Exp. 8/1/2023; 17-271741, 17-271762, Exp. 8/3/2023; 17-272051, Exp. 8/9/2023; 17-272227, Exp. 8/13/2023; 17-272343, Exp. 8/15/2023; 17-272799, Exp. 8/22/2023; 17-273173, Exp. 8/29/2023; 17-273495, 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.