May 2021 FDA Recall Thiamine Hydrochloride by Mylan Institutional Llc
D-0601-2021 - Labeling
This Class III drug recall was voluntarily initiated by Mylan Institutional Llc on May 3, 2021 for the product Thiamine Hydrochloride. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0601-2021
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.
05-03-2021
06-09-2021
2,131 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mylan Institutional LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
10-18-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 200906, Exp. Date February 2022
