Class II · Moderate risk Ongoing
Vitamin B-Complex
Reason Presence of a Foreign Substance; black particles observed in liquid
Folic Acid 5mg/mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
- Recalling firm
- TMC Acquisition LLC dba Tailor Made Compounding
- Origin
- KY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1202-2022
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.
Other Folic recalls
See all
Class II · Moderate risk Completed
Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Folic Acid Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Folic Acid 10mg/Ml Mdv Inj
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Folivane-Plus with Ascorbic Acid Precursors Iron/Folic…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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