Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, Red Mountain Compounding RX.
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
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.