D-0668-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2023
- Initiation Date
- April 28, 2023
- Termination Date
- June 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,888 bags
Product Description
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 for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Distribution Pattern
Nationwide in the USA.
Code Information
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, 37-894970, Exp 05/16/2023; 37-895276, 37-895278, 37-895281, 37-895284, 37-895285, 37-895286, 37-895289, 37-895297, Exp 05/19/2023; 37-895650, 37-895652, Exp 05/20/2023; 37-896051, 37-896052, 37-896054, 37-896055, 37-896057, 37-896058, 37-896455, Exp 05/21/2023; 37-896418, 37-896419, 37-896420, 37-896438, 37-896453, 37-896454, 37-896855, Exp 05/22/2023; 37-896814, 37-896816, 37-896818, 37-896823, 37-896824, 37-896841, 37-896843, 37-896942, Exp 05/23/2023; 37-897417, 37-897429, Exp 05/27/2023; 37-897856, 37-897857, 37-897858, 37-897880, 37-897881, 37-897882, 37-898264, Exp 05/28/2023; 37-898180, 37-898222, 37-898225, 37-898226, 37-898227, 37-898228, Exp 05/29/2023; 37-898487, 37-898488, 37-898490, Exp 05/30/2023; 37-898781, 37-898782, 37-898784, 37-898787, 37-898788, Exp 06/02/2023; 37-899102, 37-899103, 37-899104, 37-899105, Exp 06/03/2023; 37-899590, 37-899598, 37-899599, 37-900116, Exp 06/04/2023; 3700000900051, 37-900052, 37-900054, 37-900055, Exp 06/05/2023; 37-900306, 37-900309, 37-900310, 37-900311, 37-900313, 37-900314, 37-900315, 37-900316, Exp 06/06/2023