Class II · Moderate risk Ongoing
Lipo MIC +B12 Methylcobalamin for Injection
Reason Lack of Assurance of Sterility
Methylcobalamin for injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
What was recalled
Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
- Recalling firm
- Vitalab Pharmacy, Inc
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0728-2018
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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