Advanced Pharma Recalls Potassium Phosphate IV Bags Due to Sterility Concerns
Advanced Pharma Inc. is recalling 72 units of Potassium Phosphate IV bags nationwide due to a lack of assurance of 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 severity score under the rubric for significant injury or property damage reports or high-risk contamination.
Plain-English summary
Advanced Pharma Inc. is recalling 72 units of Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag. The recall is being conducted due to a lack of assurance of sterility. The affected product is identified by NDC 15082-926-25.
The recall covers two specific lots: Lot 5/23/17 1404 299-92625P with a best-use date of 8/21/2017, and Lot 5/26/2017 1250 297-92625P with a best-use date of 8/24/2017. The product was distributed nationwide within the United States.
Healthcare providers and patients should stop using the affected product 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 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 72
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 (4)
- Lot #: 5/23/17 1404 299-92625P
- BUD: 8/21/2017
- 5/26/2017 1250 297-92625P
- BUD 8/24/2017.
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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