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Class II: temporary or reversible health riskTerminated

Beacon Hill Medical Pharmacy, P.C. Hydrogen Peroxide 3% Injectable Recall

HYDROGEN PEROXIDE 3% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STER…

Beacon Hill Medical Pharmacy, P.C. · Southfield, MI

Risk level
Class II
Reported by FDA
Sep 18, 2013
Recall ID
D-967-2013
Check your lot numberHow we source this data

Summary

Beacon Hill Medical Pharmacy, P.C. recalled Hydrogen Peroxide 3% Injectable starting Jul 26, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-967-2013 on Sep 18, 2013. Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Product description

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

Lot numbers, UPCs & expiration codes

03262013@26

Where it was sold

USA nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-967-2013
Classification
Class II
Status
Terminated
Recall initiated
Jul 26, 2013
FDA report date
Sep 18, 2013
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Beacon Hill Medical Pharmacy, P.C.

Original FDA data

Every field from FDA enforcement report D-967-2013, exactly as published.

Show all FDA fields
City
Southfield
State
MI
Status
Terminated
Country
United States
Event ID
65876
Address
18161 W 13 Mile Rd
Address (line 2)
Suite A1
Code information
03262013@26
Postal code
48076-1113
Report date
Sep 18, 2013
Product type
Drugs
Recall number
D-967-2013
Classification
Class II
Recalling firm
Beacon Hill Medical Pharmacy, P.C.
Termination date
Jul 18, 2014
Reason for recall
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
USA nationwide
Recall initiation date
Jul 26, 2013
Initial firm notification
Telephone
Center classification date
Sep 10, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-967-2013, published Sep 18, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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