Drug product
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.
D-0728-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2146 bags
- Official record key
drug-enforcement:D-0728-2023
Official wording
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility