← FDA ENFORCEMENT
D-1044-2023Class 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
2,717 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

HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1

Code / lot info

Lot: 17-270603, Exp. 7/17/2023; 17-270802, Exp. 7/19/2023; 17-271073, Exp. 7/24/2023; 17-271129, Exp. 7/25/2023; 17-271254, Exp. 7/26/2023; 17-271953, Exp. 8/8/2023; 17-272022, Exp. 8/9/2023; 17-272295, Exp. 8/14/2023; 17-272616, Exp. 8/20/2023; 17-273357, Exp. 8/31/2023; 17-273501, 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.