Beacon Hill Medical Pharmacy Recalls Sodium Phosphate Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Sodium Phosphate Monobasic/Water for Injection 10% because FDA inspections raised concerns about sterility assurance and quality control.
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, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or death if administered.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling all presentations of Sodium Phosphate Monobasic/Water for Injection 10%, compounded by the firm in Southfield, Michigan. The recall is being conducted due to FDA inspectional findings that resulted in concerns associated with quality control procedures impacting sterility assurance.
The product is intended for intravenous and subcutaneous use only and is sterile. The recall covers the product distributed nationwide in the United States. No specific lot numbers or dates are provided in the source text.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions on returns or replacements.
The recalled product
- Product
- SODIUM PHOSPHATE MONOBASIC/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.
- Category
- Drug — Injectable Medication
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@5
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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