Class II · Moderate risk Completed
Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1…
Reason Lack of assurance of sterility.
Manganese Sulfate 0.1 Mg/Ml Injectable
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
What was recalled
MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Recalling firm
- Beacon Hill Medical Pharmacy, P.C.
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1018-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Manganese recalls
See all
Class II · Moderate risk Terminated
S-Manganese Chloride 0.1mg/Ml Mdv Soln
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Manganese Sulfate Monohydrate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Multi Trace
Reason Lack of sterility assurance.
Class II · Moderate risk Ongoing
Mineral Mix Schrader
Reason Lack of Assurance of Sterility
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