RecallRadar

FDA Drug recall D-1072-2023

fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, C…

On 2023-08-09 the FDA classified a Class II recall of fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, C… 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-1072-2023
ClassificationClass II
Statusterminated
Initiated2023-07-17
Published2023-08-09
Last updated2026-09-13 11:52 UTC
CompanyCentral Admixture Pharmacy Services
DistributionUS

Product

fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2

Reason

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

Identifiers

code_info
Lot: 17-270540, Exp. 7/16/2023; 17-270663, Exp. 7/18/2023; 17-271059, Exp. 7/24/2023; 17-271249, Exp. 7/26/2023; 17-271…Lot: 17-270540, Exp. 7/16/2023; 17-270663, Exp. 7/18/2023; 17-271059, Exp. 7/24/2023; 17-271249, Exp. 7/26/2023; 17-271593, Exp. 8/1/2023; 17-271742, Exp. 8/3/2023; 17-272064, Exp. 8/9/2023; 17-272106, Exp. 8/10/2023; 17-272279, Exp. 8/14/2023; 17-272530, Exp. 8/17/2023; 17-272603, Exp. 8/20/2023; 17-272776, Exp. 8/22/2023; 17-273075, Exp. 8/28/2023; 17-273344, Exp. 8/31/2023; 17-273409, Exp. 9/3/2023; 17-274221, 17-274222, Exp. 9/14/2023; 17-274414, Exp. 9/18/2023.

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-1072-2023%22

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