The Recall Desk
SevereFDA (Drugs)·D-1001-2013·Announced 2013-09-18

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.

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, 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

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.

See all 86 products in this recall →