Potassium Phosphate Injection (Advanced Pharma) – Sterility Failure (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-922-25
Brand
Advanced Pharma Inc.
Lot Codes / Batch Numbers
Lot #: 6/7/17 1446 515-92225P BUD: 9/5/2017, 6/2/17 1100 515-92225P BUD: 8/31/2017, 5/31/17 1415 382-92225P BUD: 8/29/2017.
Products Sold
Lot #: 6/7/17 1446 515-92225P BUD: 9/5/2017; 6/2/17 1100 515-92225P BUD: 8/31/2017; 5/31/17 1415 382-92225P BUD: 8/29/2017.
Advanced Pharma Inc. is recalling Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pha due to Lack of Assurance of Sterility. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026