RecallRadar

FDA Drug recall D-0731-2023

heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services,…

On 2023-05-31 the FDA classified a Class II recall of heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services,… 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

AgencyFDA Drug
Recall numberD-0731-2023
ClassificationClass II
Statusterminated
Initiated2023-04-28
Published2023-05-31
Last updated2026-09-13 11:52 UTC
CompanyCentral Admixture Pharmacy Services
DistributionUS

Product

heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7022-1.

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 # 37-888633, 37-888637, 37-888641, 37-888658, 37-888666, 37-888839, Exp 05/02/2023; 37-890332, 37-890383, 37-890394…Lot # 37-888633, 37-888637, 37-888641, 37-888658, 37-888666, 37-888839, Exp 05/02/2023; 37-890332, 37-890383, 37-890394, 37-890424, 37-890428, 37-890442, Exp 05/09/2023; 37-892010, 37-892021, 37-892046, 37-892061, 37-892116, 37-892120, 37-892150, 37-892153, Exp 05/16/2023; 37-893467, 37-893469, 37-893470, 37-893471, 37-893508, 37-893512, 37-893519, Exp 05/22/2023; 37-893925, 37-893937, 37-893939, 37-893940, 37-893958, 37-893968, Exp 05/23/2023; 37-895218, 37-895220, 37-895224, 37-895231, 37-895236, 37-895305, 37-895306, Exp 05/29/2023; 37-895754, 37-895756, 37-895757, Exp 05/30/2023

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-0731-2023%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.