RecallRadar

FDA Drug recall D-0668-2023

Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley,…

On 2023-05-31 the FDA classified a Class II recall of Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley,… 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-0668-2023
ClassificationClass II
Statusterminated
Initiated2023-04-28
Published2023-05-31
Last updated2026-09-13 11:52 UTC
CompanyCentral Admixture Pharmacy Services
DistributionUS

Product

Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0202-1.

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 # 37-890033, 37-890035, Exp 04/28/2023; 37-890518, 37-890527, 37-890536, 37-890538, Exp 04/29/2023; 37-890844, 37-8…Lot # 37-890033, 37-890035, Exp 04/28/2023; 37-890518, 37-890527, 37-890536, 37-890538, Exp 04/29/2023; 37-890844, 37-890845, Exp 04/30/2023; 37-891159, 37-891161, 37-891187, 37-891190, 37-891212, 37-891213, 37-891222, 37-891223, Exp 05/01/2023; 37-891432, 37-891433, 37-891434, 37-891435, 37-891440, 37-891442, 37-891445, 37-891446, 37-891447, Exp 05/02/2023; 37-891746, 37-891754, 37-891755, Exp 05/05/2023; 37-892005, 37-892007, Exp 05/06/2023; 37-892502, 37-892503, 37-892505, 37-892517, 37-892518, 37-892519, 37-892538, Exp 05/07/2023; 37-892871, 37-892873, 37-892874, 37-892879, 37-892880, 37-892886, 37-892887, 37-892888, 37-892899, Exp 05/08/2023; 37-893129, 37-893131, 37-893158, 37-893160, 37-893162, 37-893163, 37-893164, Exp 05/09/2023; 37-893681, 37-893689, 37-893698, 37-893760, 37-893761, 37-893762, Exp 05/13/2023; 37-894275, 37-894276, 37-894277, 37-894301, Exp 05/14/2023; 37-894651, 37-894654, 37-894658, 37-894660, 37-894662, 37-894663, Exp 05/15/2023; 37-894948, 37-894967, 37-89

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-0668-2023%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.