FDA Drug recall D-0733-2023

PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 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, 20 mg/250 mL* (80 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-0733-2023
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, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7025-1.

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 # 37-883074, Exp 04/28/2023; 37-883237, 37-883238, Exp 04/30/2023; 37-883940, Exp 05/02/2023; 37-884271, Exp 05/03/… Lot # 37-883074, Exp 04/28/2023; 37-883237, 37-883238, Exp 04/30/2023; 37-883940, Exp 05/02/2023; 37-884271, Exp 05/03/2023; 37-884749, 37-884751, Exp 05/05/2023; 37-885338, Exp 05/08/2023; 37-885756, Exp 05/09/2023; 37-886272, Exp 05/11/2023; 37-887512, Exp 05/16/2023; 37-888027, 37-888030, 37-888040, 37-888052, 37-888063, Exp 05/18/2023; 37-888314, Exp 05/21/2023; 37-890489, 37-890497, 37-890534, Exp 05/29/2023; 37-890933, Exp 05/30/2023; 37-891152, Exp 05/31/2023; 37-892985, 37-892986, 37-892995, Exp 06/07/2023; 37-893511, 37-893517, Exp 06/11/2023; 37-896481, Exp 06/21/2023; 37-897828, Exp 06/27/2023; 37-898523, Exp 06/29/2023

code_info

Lot # 37-883074, Exp 04/28/2023; 37-883237, 37-883238, Exp 04/30/2023; 37-883940, Exp 05/02/2023; 37-884271, Exp 05/03/…

Lot # 37-883074, Exp 04/28/2023; 37-883237, 37-883238, Exp 04/30/2023; 37-883940, Exp 05/02/2023; 37-884271, Exp 05/03/2023; 37-884749, 37-884751, Exp 05/05/2023; 37-885338, Exp 05/08/2023; 37-885756, Exp 05/09/2023; 37-886272, Exp 05/11/2023; 37-887512, Exp 05/16/2023; 37-888027, 37-888030, 37-888040, 37-888052, 37-888063, Exp 05/18/2023; 37-888314, Exp 05/21/2023; 37-890489, 37-890497, 37-890534, Exp 05/29/2023; 37-890933, Exp 05/30/2023; 37-891152, Exp 05/31/2023; 37-892985, 37-892986, 37-892995, Exp 06/07/2023; 37-893511, 37-893517, Exp 06/11/2023; 37-896481, Exp 06/21/2023; 37-897828, Exp 06/27/2023; 37-898523, 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-0733-2023%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.