Class II · Moderate risk Ongoing
Vitamin B-Complex
Reason Presence of a Foreign Substance; black particles observed in liquid
Folic Acid
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
What was recalled
Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Recalling firm
- Promise Pharmacy, LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0481-2019
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 Ongoing
Folic Acid 5mg/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
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