Class II · Moderate risk Ongoing
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton…
Reason Lack of Assurance of Sterility
THIAMINE HCL 100MG/ML (MDV) INJECTION, 10 ML per Vial, RXQ Compounding, 340 West State…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
THIAMINE HCL 100MG/ML (MDV) INJECTION, 10 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0950-10
- Recalling firm
- RXQ Compounding LLC
- NDC code
- 70731-0950-10
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1710-2019
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 Thiamine recalls
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Class II · Moderate risk Terminated
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA…
Reason cGMP violations
Class II · Moderate risk Terminated
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset…
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile…
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/ML (3ML VIAL) INJECTABLE…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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