Class II · Moderate risk
B12 Hydroxocobalamin for Injection
Lack of Assurance of Sterility
Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL
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
Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335
Affected NDC
33216-7833-05
Compare with the code on your package — it is the most precise check available.
Drug: Hydroxocobalamin
- Recalling firm
- KRS Global Biotechnology, Inc
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0115-2020 · 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 KRS Global Biotechnology, Inc
All 2019 recalls
Class II · Moderate risk
Isoproterenol HCL
Lack of Assurance of Sterility
Class II · Moderate risk
L-Asparaginase Lyophilized
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin 9A/B Lyophilized
Lack of Assurance of Sterility
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