← FDA ENFORCEMENT
D-1060-2023Class 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
5,259 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, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1

Code / lot info

Lot: 17-270534, Exp. 7/16/2023; 17-270705, Exp. 7/18/2023; 17-270782, 17-270797, 17-270798, Exp. 7/19/2023; 17-270968, Exp. 7/23/2023; 17-271105, 17-271154, Exp. 7/25/2023; 17-271251, Exp. 7/26/2023; 17-271330, Exp. 7/27/2023; 17-271418, Exp. 7/30/2023; 17-271746, 17-271758, Exp. 8/3/2023; 17-272108, Exp. 8/10/2023; 17-272257, Exp. 8/13/2023; 17-272344, 17-272355, Exp. 8/15/2023; 17-272442, Exp. 8/16/2023; 17-272801, Exp. 8/22/2023; 17-273511, Exp. 9/4/2023; 17-273576, 17-273611, Exp. 9/5/2023; 17-274048, 17-274050, Exp. 9/12/2023.

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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.