Class II · Moderate risk
Lipo MIC +B12 Methylcobalamin for Injection
Lack of Assurance of Sterility
Vitamin Supplement
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/pyridoxine/methionine/inositol/choline bitartrate USP) capsules, 60, 120 or 180 count vials, Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476.
Drug: Methylcobalamin
- Recalling firm
- Glades Drugs Inc.
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0669-2016 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
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 wrong potency / content recalls from 2015
All wrong potency / content recalls
Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk
Lindane Lotion
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Class II · Moderate risk
Xanax (alprazolam)
Subpotent Drug
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