FDA Drug recall D-0716-2023

potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdri…

FDA Drug
Class II
terminated
Published 2023-05-31

On 2023-05-31 the FDA classified a Class II recall of potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdri… 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-0716-2023
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

potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6060-1.

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 # 37-883769, Exp 05/02/2023; 37-884449, Exp 05/04/2023; 37-885585, Exp 05/09/2023; 37-885922, Exp 05/10/2023; 37-88… Lot # 37-883769, Exp 05/02/2023; 37-884449, Exp 05/04/2023; 37-885585, Exp 05/09/2023; 37-885922, Exp 05/10/2023; 37-886526, Exp 05/14/2023; 37-887387, Exp 05/16/2023; 37-887659, 37-887662, Exp 05/17/2023; 37-889064, Exp 05/23/2023; 37-889735, 37-889745, Exp 05/25/2023; 37-890036, 37-890055, Exp 05/28/2023; 37-890934, Exp 05/30/2023; 37-892890, Exp 06/07/2023; 37-893813, Exp 06/12/2023; 37-894317, Exp 06/13/2023; 37-895275, Exp 06/18/2023; 37-896822, 37-896852, Exp 06/22/2023; 37-897826, 37-897839, Exp 06/27/2023

code_info

Lot # 37-883769, Exp 05/02/2023; 37-884449, Exp 05/04/2023; 37-885585, Exp 05/09/2023; 37-885922, Exp 05/10/2023; 37-88…

Lot # 37-883769, Exp 05/02/2023; 37-884449, Exp 05/04/2023; 37-885585, Exp 05/09/2023; 37-885922, Exp 05/10/2023; 37-886526, Exp 05/14/2023; 37-887387, Exp 05/16/2023; 37-887659, 37-887662, Exp 05/17/2023; 37-889064, Exp 05/23/2023; 37-889735, 37-889745, Exp 05/25/2023; 37-890036, 37-890055, Exp 05/28/2023; 37-890934, Exp 05/30/2023; 37-892890, Exp 06/07/2023; 37-893813, Exp 06/12/2023; 37-894317, Exp 06/13/2023; 37-895275, Exp 06/18/2023; 37-896822, 37-896852, Exp 06/22/2023; 37-897826, 37-897839, Exp 06/27/2023

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-0716-2023%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.