Class II · Moderate risk Ongoing
Lipo MIC +B12 Methylcobalamin for Injection
Reason Lack of Assurance of Sterility
MIC+Methyl B12 injection Methionine Inositol…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of processing controls
What was recalled
MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS
- Recalling firm
- Promise Pharmacy, LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0803-2021
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 Methylcobalamin recalls
See all
Class II · Moderate risk Ongoing
B12 Methylcobalamin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Methylcobalamin Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methylcobalamin Injection Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methylcobalamin 12.5mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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