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
Drug Recall
Official source record
- Recall number
- D-0601-2021
- Event ID
- 87803
- Classification
- Class III
- Status
- Terminated
- Recalling company
- Mylan Institutional LLC
- Reason for recall
- 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.
- Report date
- June 9, 2021
- Recall initiation date
- May 3, 2021
- Termination date
- October 18, 2022
- Distribution pattern
- Nationwide within the United States
Drug product identifiers
- Manufacturer
- Mylan Institutional LLC
- Brand name
- THIAMINE HYDROCHLORIDE
- Generic name
- THIAMINE HYDROCHLORIDE
- Substance name
- THIAMINE HYDROCHLORIDE
- Product NDC
- 67457-196
- Package NDCs
- 67457-196-00; 67457-196-02
- Routes
- INTRAMUSCULAR; INTRAVENOUS
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class III mean?
A situation in which use of or exposure to a product is not likely to cause adverse health consequences.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.
