The Recall Desk
SevereFDA (Drugs)·D-967-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Hydrogen Peroxide Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Hydrogen Peroxide 3% Injectable because FDA inspections raised concerns about quality control and sterility assurance.

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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of sterility failure in an injectable product.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C. is recalling Hydrogen Peroxide 3% Injectable, all presentations, for intravenous and subcutaneous use only. The product is sterile, prescription-only, and was compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, MI.

The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance.

The distribution pattern for this recall is USA nationwide. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
HYDROGEN PEROXIDE 3% INJECTABLE, 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)

  • 03262013@26

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 →