Recall Record

Middletown, NY, United States

RIJ Pharmaceutical LLC recalls

1 recall recorded since 2018, most recently on 7 May 2018. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0

Terminated Class II Drugs

Recall started
7 May 2018
Terminated
7 April 2023
Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall numbers
D-0850-2018, D-0842-2018, D-0845-2018, D-0846-2018, D-0844-2018, D-0853-2018, D-0847-2018, D-0843-2018, D-0848-2018, D-0849-2018, D-0851-2018, D-0852-2018

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.