RecallRadar

FDA Drug recall D-0962-2023

phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenu…

On 2023-08-09 the FDA classified a Class II recall of phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenu… by Central Admixture Pharmacy Services, citing lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0962-2023
ClassificationClass II
Statusterminated
Initiated2023-07-14
Published2023-08-09
Last updated2026-09-13 11:52 UTC
CompanyCentral Admixture Pharmacy Services
DistributionUS

Product

phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.

Reason

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Identifiers

code_infoLot: 36-249691, 36-249692, Exp. 8/20/2023; 36-250052, 36-250053, Exp. 8/22/2023; 36-251062, Exp. 8/24/2023; 36-251992, Exp. 8/30/2023; 36-252467, Exp. 9/3/2023

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-0962-2023%22

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