D-0601-2021 Class III Terminated
FDA drug recall D-0601-2021 was initiated by Mylan Institutional LLC on May 3, 2021 and is designated Class III. 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. The recall status is terminated (terminated October 18, 2022). Affected quantity: 2,131 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- June 9, 2021
- Initiation Date
- May 3, 2021
- Termination Date
- October 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,131 cartons
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
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.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 200906, Exp. Date February 2022