Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
Vitamin D3 100,000 Unit/mL, in olive oil, (30 ML). Compounded by Tri-Coast Pharmacy
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.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
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