FDA Recalls IV Potassium Phosphate Solution Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 7,469 bags of potassium phosphate IV solution nationwide because decontamination validation data is lacking, creating a sterility assurance gap.
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: This is an FDA Class II recall of an intravenous medication with unvalidated sterility assurance. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, placing it at the High severity level per the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling potassium phosphate 15 mmole in 0.9% sodium chloride 250 mL IV bags (NDC: 72196-6060-1) distributed nationwide. The recall affects 7,469 bags with lot numbers and expiration dates ranging from July through September 2023.
The recall was initiated due to lack of assurance of sterility. Validation data for the facility's decontamination cycles was found to be insufficient, meaning the product was not properly validated for safety against contamination.
Healthcare facilities that received affected batches should immediately discontinue use and contact Central Admixture Pharmacy Services or the FDA. Patients who may have received the product should consult their healthcare provider if they experience signs of infection.
The recalled product
- Product
- potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6060-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous Solution
- 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 (20)
- Lot: 36-239332
- Exp. 7/11/2023
- 36-241113
- Exp. 7/18/2023
- 36-242467
- 7/25/2023
- 36-243530
- 36-243659
- Exp. 7/30/2023
- 36-244888
- 8/1/2023
- 36-245657
- 36-245658
- Exp. 8/2/2023
- 36-246835
- Exp. 8/7/2023
- 36-247595
- Exp. 8/9/2023
- 36-248736
- Exp. 8/15/2023
Distribution
Distributed nationwide across the United States.
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