Class III · Low risk Ongoing
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit
Reason Failed Tablet/Capsule Specifications
Sodium Phosphate Monobasic/Water for Injection 10%
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
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
- Recalling firm
- Beacon Hill Medical Pharmacy, P.C.
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1001-2013
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.
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Class II · Moderate risk Terminated
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Class II · Moderate risk Terminated
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Class II · Moderate risk Terminated
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Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
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