PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: June 9, 2021 Initiated: May 3, 2021 #D-0601-2021

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.

Details

Recalling Firm
Mylan Institutional LLC
Units Affected
2,131 cartons
Distribution
Nationwide within the United States
Location
Rockford, IL

Frequently Asked Questions

What product 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. Recalled by Mylan Institutional LLC. Units affected: 2,131 cartons.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 9, 2021. Severity: Low. Recall number: D-0601-2021.