Thiamine HCl Injection Recall: Vials with Incorrect Lot Numbers
Mylan Institutional LLC is recalling Thiamine Hydrochloride Injection USP 200 mg/2 mL due to vials labeled with incorrect lot numbers. The cartons contain the correct lot number 200906 but vials inside are labeled with lot number 200901.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This recall is classified as FDA Class III and involves only a labeling discrepancy—a mismatch between the carton lot number and the vial lot number. No safety hazard, contamination, or injury has been reported. The recall is documentation-related rather than a product quality or safety issue.
Plain-English summary
Mylan Institutional LLC is recalling Thiamine Hydrochloride Injection, USP 200 mg/2 mL (100 mg/mL) in 2 mL vials. The recall affects 2,131 cartons distributed nationwide within the United States.
The reason for the recall is a labeling discrepancy: cartons bearing the correct lot number 200906 contain vials that are labeled with an incorrect lot number 200901. This mismatch between the carton label and the vial label could create confusion during medication handling and verification.
The affected product is a prescription injection manufactured by Mylan Institutional in Galway, Ireland, and manufactured for Mylan Institutional LLC in Rockford, Illinois. The lot number in question is 200906 with an expiration date of February 2022 (NDC 67457-196-02).
Patients and healthcare providers who have this product should verify the lot numbers on both the carton and vials before use. Healthcare facilities should contact their pharmacy supplier or Mylan Institutional LLC for instructions on product return or replacement.
The recalled product
- Product
- THIAMINE HYDROCHLORIDE (THIAMINE HYDROCHLORIDE)
- Brand
- THIAMINE HYDROCHLORIDE
- Manufacturer
- Mylan Institutional LLC
- Affected units
- 2,131
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 200906
- Exp. Date February 2022
Distribution
Distributed nationwide across the United States.
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