← FDA ENFORCEMENT
D-1057-2023Class 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
1,389 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 Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2013-1

Code / lot info

Lot: 17-270683, Exp 7/18/2023; 17-271119, Exp 7/25/2023; 17-271339, Exp 7/27/2023; 17-272202, Exp 8/10/2023; 17-272241, Exp 8/13/2023; 17-272783, Exp 8/22/2023; 17-273431, Exp 9/3/2023; 17-273615, Exp 9/5/2023

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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.