The Recall Desk
HighFDA (Drugs)·D-0990-2023·Announced 2023-08-09

Potassium Phosphate IV Bags Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling potassium phosphate intravenous bags due to lack of sterility assurance and missing validation data for decontamination processes. The recall affects 234 bags distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a sterile injectable medication. No illnesses or injuries have been reported, but the lack of sterility assurance in an intravenous drug product represents a significant risk of harm.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling potassium phosphate 30 mmole added to 0.9% sodium chloride 500mL intravenous bags. The recall was issued because the manufacturer lacks assurance of sterility and does not have adequate validation data for its decontamination cycles.

The affected product is potassium phosphate IV bag with NDC 72196-7016-1, Lot 36-256240, expiring 9/12/2023. A total of 234 bags were distributed nationwide in the USA.

This is an FDA Class II recall assigned recall number D-0990-2023.

The recalled product

Product
potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7016-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Intravenous Medication
Hazard
  • sterility-assurance
  • contamination-risk

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 (2)

  • Lot: 36-256240
  • Exp.9/12/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category