Drug product
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25
D-0954-2017
Product summary
- Event
- Event 77595
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72 units
- Official record key
drug-enforcement:D-0954-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 5/23/17 1404 299-92625P, BUD: 8/21/2017; 5/26/2017 1250 297-92625P, BUD 8/24/2017.
Distribution pattern: Nationwide with the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility