D-0731-2023 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
- 11117 bags
Product Description
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 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 # 37-888633, 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