Class II · Moderate risk
thiamine HCl
Lack of Assurance of Sterility
Thiamine HCl Injection (Thiamine Hydrochloride)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institutional, Galway, Ireland. NDC: 67457-196-02
Affected NDC
67457-0196-02
Compare with the code on your package — it is the most precise check available.
Drug: Thiamine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Thiamine Hydrochloride NDC 67457-0196 |
100 mg/mL | Injection, Solution Intramuscular|intravenous |
Mylan Institutional LLC | Rx |
- Recalling firm
- Mylan Institutional LLC
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0601-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 0.9% Sodium Chloride Injection USP
cGMP violations
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.
Other recalls by Mylan Institutional LLC
All 2021 recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets
Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
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