Medications & Supplements/Prescription Drugs

Thiamine HCl Injection Recalled for Incorrect Lot and Expiration Labeling

Agency Publication Date: June 1, 2021

Summary

Mylan Institutional LLC is recalling 2,131 cartons of Thiamine HCl Injection (thiamine hydrochloride), USP 200 mg/2 mL (100mg/mL). The recall was issued because cartons labeled with the correct lot number (200906) contain individual medicine vials labeled with an incorrect lot number (200901). No incidents or injuries have been reported in connection with this labeling error.

Risk

The incorrect lot and expiration information on the vials could lead to confusion regarding the drug's shelf life or manufacturing history, potentially resulting in the use of the product beyond its intended expiration date.

What You Should Do

This recall affects Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), sold in cartons containing 25 multi-dose vials (NDC 67457-196-02).
Identify affected products by checking for carton lot number 200906 with an expiration date of February 2022; the vials inside these cartons may be incorrectly labeled with lot number 200901.
Stop using the recalled product immediately.
Contact Mylan Institutional LLC or your distributor to arrange for the return of any remaining inventory from these lots.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report concerns.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL)

Variants: 200 mg/2 mL (100mg/mL), 2 mL multi-dose vial, Packaged in 25 vials per carton

Lot Numbers:

200906 (Exp February 2022)

200901

NDC:

67457-196-02

Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87803

Status: Resolved

Manufacturer: Mylan Institutional LLC

Sold By: wholesalers; institutional pharmacies

Manufactured In: Ireland, United States

Units Affected: 2,131 cartons

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), sold in cartons containing 25 multi-dose vials (NDC 67457-196-02).

Identify affected products by checking for carton lot number 200906 with an expiration date of February 2022; the vials inside these cartons may be incorrectly labeled with lot number 200901.

Stop using the recalled product immediately.

Contact Mylan Institutional LLC or your distributor to arrange for the return of any remaining inventory from these lots.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report concerns.