RecallRadar

FDA Drug recall D-1061-2023

fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbro…

On 2023-08-09 the FDA classified a Class II recall of fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbro… 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-1061-2023
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, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5

Reason

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

Identifiers

code_info
Lot: 17-270584, 17-270586, 17-270597, 17-270613, Exp. 7/17/2023; 17-270655, 17-270659, 17-270741, Exp. 7/18/2023; 17-27…Lot: 17-270584, 17-270586, 17-270597, 17-270613, Exp. 7/17/2023; 17-270655, 17-270659, 17-270741, Exp. 7/18/2023; 17-270872, 17-270875, Exp. 7/20/2023; 17-271040, 17-271041, 17-271042, 17-271058, 17-271066, 17-271071, 17-271080, Exp. 7/24/2023; 17-271111, 17-271148, 17-271150, 17-271151, 17-271152, 17-271166, Exp. 7/25/2023; 17-271241, 17-271267, Exp. 7/26/2023; 17-271402, 17-271407, 17-271413, 17-271429, Exp. 7/30/2023; 17-271555, 17-271556, 17-271560, 17-271594, Exp. 8/1/2023; 17-271754, Exp. 8/3/2023; 17-271797, 17-271799, 17-271821, 17-271842, Exp. 8/6/2023; 17-271888, 17-271889, Exp. 8/7/2023; 17-271949, 17-271950, Exp. 8/8/2023; 17-272021, 17-272041, Exp. 8/9/2023; 17-272285, 17-272292, 17-272309, 17-272316, Exp. 8/14/2023; 17-272705, 17-272708, 17-272709, 17-272722, 17-272725, Exp. 8/21/2023; 17-272784, 17-272810, Exp. 8/22/2023; 17-272916, Exp. 8/23/2023; 17-272981, 17-272982, 17-272983, 17-272984, Exp. 8/24/2023; 17-273144, 17-273145, 17-273158, 17-273159, 17-273165, Exp. 8/29

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-1061-2023%22

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