Class II · Moderate risk
B12 Hydroxocobalamin for Injection
Lack of Assurance of Sterility
C-Hydroxocobalamin 5 Mg/Ml Injection Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
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
C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Drug: Hydroxocobalamin
- Recalling firm
- Colonia Care Pharmacy
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0012-2020 · 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 Hydroxocobalamin recalls
See all
Class II · Moderate risk
Hydroxocobalamin-Pf- 1mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Hydroxocobalamin 25MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL
Lack of assurance of sterility.
Other recalls by Colonia Care Pharmacy
All 2019 recalls
Class II · Moderate risk
C-Verapamil 2.5mg/Ml Inj Soln
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Urea 40% Bladder Instill
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Tacrolimus 0.03% Ophthal Suspension
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Phenol/Cottonseed Oil Inj 5%
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
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