Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Defective Delivery System: Product may contain leaking capsules.
VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305
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 CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
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