RecallRadar

FDA Drug recall D-1073-2023

ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego,…

On 2023-08-09 the FDA classified a Class II recall of ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego,… 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-1073-2023
ClassificationClass II
Statusterminated
Initiated2023-07-17
Published2023-08-09
Last updated2026-09-13 11:52 UTC
CompanyCentral Admixture Pharmacy Services
DistributionUS

Product

ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1

Reason

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

Identifiers

code_info
Lot: 17-270545, Exp. 7/16/2023; 17-270614, Exp. 7/17/2023; 17-270885, 17-270897, Exp. 7/20/2023; 17-270980, 17-270992,…Lot: 17-270545, Exp. 7/16/2023; 17-270614, Exp. 7/17/2023; 17-270885, 17-270897, Exp. 7/20/2023; 17-270980, 17-270992, Exp. 7/23/2023; 17-271268, Exp. 7/26/2023; 17-271338, Exp. 7/27/2023; 17-271426, 17-271428, Exp. 7/30/2023; 17-271691, Exp. 8/2/2023; 17-271843, Exp. 8/6/2023; 17-271963, Exp. 8/8/2023; 17-272136, Exp. 8/10/2023; 17-272215, Exp. 8/13/2023; 17-272304, Exp. 8/14/2023; 17-272379, Exp. 8/15/2023; 17-272462, Exp. 8/16/2023; 17-272641, Exp. 8/20/2023; 17-272698, Exp. 8/21/2023; 17-273602, 17-273627, Exp. 9/5/2023; 17-273883, Exp. 9/10/2023.

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-1073-2023%22

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