Class II · Moderate risk
thiamine HCl
Lack of Assurance of Sterility
Thiamine HCl 0.9% Sodium Chloride Injection USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP violations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56
Affected NDC
71506-0079-56
Compare with the code on your package — it is the most precise check available.
Drug: Thiamine
- Recalling firm
- Fresenius Kabi Compounding, LLC
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0023-2025 · 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 Thiamine recalls
See all
Class II · Moderate risk
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution
Presence of Particulate Matter.
Class II · Moderate risk
B-Complex
Presence of Particulate Matter.
Class II · Moderate risk
Thiamine/Ribofla/Niacinami/Dexpanth/Pyridox/Hydroxycobal 25mg/25mg/25mg/25mg/25mg/20mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Thiamine Hydrochloride 3000 mg/30 mL
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Other recalls by Fresenius Kabi Compounding, LLC
All 2024 recalls
Class II · Moderate risk
vancomycin HCl
Lack of Assurance of Sterility
Class II · Moderate risk
vancomycin HCl
Lack of Assurance of Sterility
Class II · Moderate risk
thiamine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
ketamine HCl
Lack of Assurance of Sterility
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