Class II · Moderate risk Ongoing
B6 (Pyridoxine HCl) for Injections
Reason Lack of Assurance of Sterility
Thiamine/Ribofla/Niacinami/Dexpanth/Pyridox/Hydroxycobal…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
What was recalled
THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/ML (3ML VIAL) INJECTABLE THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/METHYLFOLATE/METHYLCOBAL 10MG/2.5MG/25MG/5MG/5MG/10MG/10MG/ML (1ML VIAL) INJECTABLE THIAMINE/RIBOFLAVIN/NIACINAMIDE/DEXPANTHENOL/PYRIDOXINE 50MG/1MG/100MG/3MG/2MG/ML (30ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Recalling firm
- Pharmacy Innovations
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0239-2023
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Pyridoxine recalls
See all
Class II · Moderate risk Ongoing
LX Bioboost Plus
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pyridoxine HCL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
B-Complex
Reason Presence of Particulate Matter.
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