Beacon Hill Medical Pharmacy Recalls Sodium Phosphate Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Sodium Phosphate Dibasic/Water for Injection 10% because FDA inspections raised concerns about quality control and sterility assurance.
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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility assurance failures in injectable products which carry significant risk.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling all presentations of Sodium Phosphate Dibasic/Water for Injection 10%. The product is compounded for intravenous and subcutaneous use only and is sterile, prescription-only medication.
The recall was initiated following FDA inspectional findings that identified concerns associated with quality control procedures. These findings impacted the assurance of sterility for the affected product. The recall covers the product distributed nationwide in the United States.
Healthcare providers and patients should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Manufacturer
- Beacon Hill Medical Pharmacy, P.C.
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)
- 01242013@11
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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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