Class II · Moderate risk
Methyl-Cobalamin injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
HCG/Hydroxycobalamin 5
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
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
HCG/Hydroxycobalamin 5,000 IU/5 mg Vial. Compounded by Tri-Coast Pharmacy
Drug: Cobalamin
- Recalling firm
- Tri-Coast Pharmacy
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0262-2017 · 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.
Other Cobalamin recalls
See all
Class II · Moderate risk
Methyl-Cobalamin injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Methyl-Cobalamin injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Methyl-Cobalamin injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
M-Cobalamin 2/Folate 5mg/mL Injection
Lack of Assurance of Sterility
Other recalls by Tri-Coast Pharmacy
All 2016 recalls
Class II · Moderate risk
Vitamin D3 100
Lack of Assurance of Sterility
Class II · Moderate risk
Ultra Slim Shot
Lack of Assurance of Sterility
Class II · Moderate risk
Ultra Cocktail #2
Lack of Assurance of Sterility
Class II · Moderate risk
Ultra Amino Energy Cocktail
Lack of Assurance of Sterility
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