Mylan Institutional LLC recalls Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx on…

Recall date

May 3, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0601-2021

FDA classification

Class III

Brand / firm

Mylan Institutional LLC

Sold / distributed

Nationwide within the United States

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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