← FDA ENFORCEMENT
D-1058-2023Class 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
2,077 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, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1

Code / lot info

Lot: 17-270770, Exp. 7/19/2023; 17-271061, Exp. 7/24/2023; 17-271419, Exp. 7/30/2023; 17-271678, Exp. 8/2/2023; 17-272124, Exp. 8/10/2023; 17-272302, Exp. 8/14/2023; 17-272518, Exp. 8/17/2023; 17-273493, Exp. 9/4/2023; 17-273671, Exp. 9/6/2023.

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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.