Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10
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 Presence of a Foreign Substance; black particles observed in liquid
Reason Lack of assurance of sterility.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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