FDA Drug recall D-0724-2023

PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc.…

FDA Drug
Class II
terminated
Published 2023-05-31

On 2023-05-31 the FDA classified a Class II recall of PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc.… by Central Admixture Pharmacy Services, citing lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0724-2023
Classification	Class II
Status	terminated
Initiated	2023-04-28
Published	2023-05-31
Last updated	2026-09-13 11:52 UTC
Company	Central Admixture Pharmacy Services
Distribution	US

Product

PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6092-1.

Reason

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Identifiers

code_info	Lot # 37-883910, Exp 05/02/2023; 37-884221, Exp 05/03/2023; 37-884756, Exp 05/05/2023; 37-885358, Exp 05/08/2023; 37-88… Lot # 37-883910, Exp 05/02/2023; 37-884221, Exp 05/03/2023; 37-884756, Exp 05/05/2023; 37-885358, Exp 05/08/2023; 37-885683, Exp 05/09/2023; 37-886267, 37-886268, Exp 05/11/2023; 37-886539, Exp 05/14/2023; 37-887458, 37-887459, Exp 05/16/2023; 37-888080, Exp 05/18/2023; 37-889192, Exp 05/23/2023; 37-889575, 37-889578, Exp 05/24/2023; 37-889852, 37-889855, Exp 05/25/2023; 37-890120, 37-890126, Exp 05/28/2023; 37-891485, 37-891491, Exp 06/01/2023; 37-892901, 37-892966, Exp 06/07/2023; 37-893236, 37-893237, Exp 06/08/2023; 37-893997, Exp 06/12/2023; 37-894777, Exp 06/14/2023; 37-895317, 37-895321, 37-895323, Exp 06/18/2023; 37-896201, Exp 06/20/2023; 37-896923, Exp 06/22/2023; 37-898558, Exp 06/29/2023

code_info

Lot # 37-883910, Exp 05/02/2023; 37-884221, Exp 05/03/2023; 37-884756, Exp 05/05/2023; 37-885358, Exp 05/08/2023; 37-88…

Lot # 37-883910, Exp 05/02/2023; 37-884221, Exp 05/03/2023; 37-884756, Exp 05/05/2023; 37-885358, Exp 05/08/2023; 37-885683, Exp 05/09/2023; 37-886267, 37-886268, Exp 05/11/2023; 37-886539, Exp 05/14/2023; 37-887458, 37-887459, Exp 05/16/2023; 37-888080, Exp 05/18/2023; 37-889192, Exp 05/23/2023; 37-889575, 37-889578, Exp 05/24/2023; 37-889852, 37-889855, Exp 05/25/2023; 37-890120, 37-890126, Exp 05/28/2023; 37-891485, 37-891491, Exp 06/01/2023; 37-892901, 37-892966, Exp 06/07/2023; 37-893236, 37-893237, Exp 06/08/2023; 37-893997, Exp 06/12/2023; 37-894777, Exp 06/14/2023; 37-895317, 37-895321, 37-895323, Exp 06/18/2023; 37-896201, Exp 06/20/2023; 37-896923, Exp 06/22/2023; 37-898558, Exp 06/29/2023

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-0724-2023%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.