RecallRadar

FDA Drug recall D-1054-2023

fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbr…

On 2023-08-09 the FDA classified a Class II recall of fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbr… 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-1054-2023
ClassificationClass II
Statusterminated
Initiated2023-07-17
Published2023-08-09
Last updated2026-09-13 11:52 UTC
CompanyCentral Admixture Pharmacy Services
DistributionUS

Product

fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3

Reason

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

Identifiers

code_info
Lot: 17-271133, 17-271155, Exp. 7/25/2023; 17-271568, 17-271569, Exp. 8/1/2023; 17-271741, 17-271762, Exp. 8/3/2023; 17…Lot: 17-271133, 17-271155, Exp. 7/25/2023; 17-271568, 17-271569, Exp. 8/1/2023; 17-271741, 17-271762, Exp. 8/3/2023; 17-272051, Exp. 8/9/2023; 17-272227, Exp. 8/13/2023; 17-272343, Exp. 8/15/2023; 17-272799, Exp. 8/22/2023; 17-273173, Exp. 8/29/2023; 17-273495, Exp. 9/4/2023.

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-1054-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.