The Recall Desk
SevereFDA (Drugs)·D-0954-2017·Announced 2017-07-19

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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.

See all 4 products in this recall →