Recall Record

Tarrytown, NY, United States

Medtech Products, Inc. recalls

2 recalls recorded since 2018, most recently on 26 July 2019. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0

Terminated Class II Drugs

Recall started
26 July 2019
Terminated
10 March 2021
Reason
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Distribution
Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
Initiated
Voluntary: Firm initiated
Recall numbers
D-1826-2019, D-1828-2019, D-1832-2019, D-1833-2019, D-1834-2019, D-1829-2019, D-1831-2019, D-1830-2019, D-1823-2019, D-1822-2019, D-1825-2019, D-1835-2019 and 2 more

Terminated Class II Drugs

Recall started
7 March 2019
Terminated
18 November 2020
Reason
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Distribution
Nationwide in the United States.
Initiated
Voluntary: Firm initiated
Recall number
D-1012-2019

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.