Drug 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
D-0601-2021
Product summary
- Event
- Event 87803
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,131 cartons
- Official record key
drug-enforcement:D-0601-2021
Official wording
Reason: 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.
Code information: Lot #: 200906, Exp. Date February 2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing