Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Methylcobalamin 1mg/mL Injection w/Pres.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500
Drug: Alcohol
- Recalling firm
- La Vita Compounding Pharmacy, LLC
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0921-2018 · 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 Alcohol recalls
See all
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Other recalls by La Vita Compounding Pharmacy, LLC
All 2018 recalls
Class II · Moderate risk
Glutathione 200mg/mL Injection w/Pres.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Class II · Moderate risk
Methyl Folate CA+ 1mg/ml Injection w/Pres.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
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