Advanced Pharma Recalls Potassium Phosphate Bags Due to Sterility Concerns
Advanced Pharma Inc. is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride bags because the company cannot assure the product's sterility.
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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Advanced Pharma Inc. is recalling specific lots of Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bags. The recall is being conducted because the company lacks assurance of the sterility of the affected product.
The affected product is identified by the NDC 15082-924-25. The specific lot number is 5/31/17 1416 382-92425P, with a best-use-by date of 8/29/2017. The product was distributed nationwide within the United States.
Healthcare providers and consumers should stop using the affected product and contact Advanced Pharma Inc. at (877) 794-0404 for further instructions or to arrange for a return.
The recalled product
- Product
- Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — IV Solution
- Hazard
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 (1)
- Lot #: 5/31/17 1416 382-92425P 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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