Mylan Institutional LLC: Drug Recall
Recall #D-0601-2021 · 05/03/2021
Class III: Low Risk
Recall Details
- Recall Number
- D-0601-2021
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Mylan Institutional LLC
- Status
- Terminated
- Date Initiated
- 05/03/2021
- Location
- Rockford, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,131 cartons
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.
Product Description
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
Distribution Pattern
Nationwide within the United States
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.