Class II · Moderate risk
Lipo MIC +B12 Methylcobalamin for Injection
Lack of Assurance of Sterility
Methylcobalamin 12mg/ml injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Drug: Methylcobalamin
- Recalling firm
- Valgene Incorporated dba Cape Drugs
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0283-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Methylcobalamin recalls
See all
Class II · Moderate risk
B12 Methylcobalamin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin Injection Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin 12.5mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Other recalls by Valgene Incorporated dba Cape Drugs
All 2021 recalls
Class II · Moderate risk
B-Complex
Lack of Processing Controls
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