D-0728-2023 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
- 2146 bags
Product Description
potassium phosphate 30 mmole added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7016-1.
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 # 37-883219, Exp 04/30/2023; 37-885926, Exp 05/10/2023; 37-887382, Exp 05/16/2023; 37-889455, Exp 05/24/2023; 37-890060, Exp 05/28/2023; 37-893444, Exp 06/11/2023; 37-894987, Exp 06/15/2023