RecallRadar

FDA Drug recall D-1049-2023

HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Roa…

On 2023-08-09 the FDA classified a Class II recall of HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Roa… by Central Admixture Pharmacy Services, citing lack of assurance of sterility: Lack of validation data for sanitization cycles.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1049-2023
ClassificationClass II
Statusterminated
Initiated2023-07-17
Published2023-08-09
Last updated2026-09-13 11:52 UTC
CompanyCentral Admixture Pharmacy Services
DistributionUS

Product

HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2

Reason

Lack of assurance of sterility: Lack of validation data for sanitization cycles

Identifiers

code_info
Lot: 17-270675, 17-270683, Exp. 7/18/2023; 17-271147, 17-271119, Exp. 7/25/2023; 17-271339, Exp. 7/27/2023; 17-271679,…Lot: 17-270675, 17-270683, Exp. 7/18/2023; 17-271147, 17-271119, Exp. 7/25/2023; 17-271339, Exp. 7/27/2023; 17-271679, Exp. 8/2/2023; 17-272202, Exp. 8/10/2023; 17-272241, Exp. 8/13/2023; 17-272375, Exp. 8/15/2023; 17-272783, Exp. 8/22/2023; 17-273438, 17-273431, Exp. 9/3/2023; 17-273615, Exp. 9/5/2023; 17-273789, 9/7/2023.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1049-2023%22

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