Recalls / Class III
Class IIID-0601-2021
Product
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
- Brand name
- Thiamine Hydrochloride
- Generic name
- Thiamine Hydrochloride
- Active ingredient
- Thiamine Hydrochloride
- Route
- Intramuscular, Intravenous
- NDC
- 67457-196
- FDA application
- ANDA091623
- Affected lot / code info
- Lot #: 200906, Exp. Date February 2022
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.
Recalling firm
- Firm
- Mylan Institutional LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4901 Hiawatha Dr, Rockford, Illinois 61103-1287
Distribution
- Quantity
- 2,131 cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-05-03
- FDA classified
- 2021-06-01
- Posted by FDA
- 2021-06-09
- Terminated
- 2022-10-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0601-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.