Advanced Pharma Recalls Potassium Phosphate Injection Due to Sterility Concerns
Advanced Pharma Inc. is recalling specific lots of Potassium Phosphate Injection due to a lack of assurance of sterility. The product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Advanced Pharma Inc. is recalling specific lots of Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is identified by NDC 15082-922-25. The recall includes lots with the following codes and best-use dates: 6/7/17 1446 515-92225P (BUD: 9/5/2017), 6/2/17 1100 515-92225P (BUD: 8/31/2017), and 5/31/17 1415 382-92225P (BUD: 8/29/2017). The product was distributed nationwide within the United States.
Healthcare providers and consumers should stop using the affected lots and contact Advanced Pharma Inc. at (877) 794-0404 for further instructions.
The recalled product
- 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
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 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.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Advanced Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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