Class II · Moderate risk Completed
Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate 20 mcg/mL Copper Gluconate 0.2 mg/mL…
Reason Lack of assurance of sterility.
MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE…
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, 10 ML vial, Red Mountain Compounding Rx
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
MANGANESE SULFATE MONOHYDRATE (PFV) 0.1MG/ML INJ, 10 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise…
Reason Lack of sterility assurance.
Class II · Moderate risk Ongoing
Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + Sodium Molybdate 250 mcg/ml +…
Reason Lack of Assurance of Sterility
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