Recall Record

Belleville, NJ, United States

US Pharmaceuticals Inc. recalls

3 recalls recorded since 2018, most recently on 19 November 2020. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0

Terminated Class II Drugs

Recall started
19 November 2020
Terminated
1 February 2022
Reason
Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
Distribution
Distributed in RI
Initiated
Voluntary: Firm initiated
Recall number
D-0113-2021

Terminated Class II Drugs

Recall started
11 July 2019
Terminated
25 June 2020
Reason
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Distribution
Distributed Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall numbers
D-1741-2019, D-1730-2019, D-1729-2019, D-1737-2019, D-1738-2019, D-1739-2019, D-1740-2019, D-1731-2019, D-1736-2019, D-1725-2019, D-1733-2019, D-1732-2019 and 6 more

Terminated Class II Drugs

Recall started
7 December 2018
Terminated
6 November 2023
Reason
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Distribution
Nationwide within the United States
Initiated
Voluntary: Firm initiated
Recall numbers
D-0425-2019, D-0427-2019, D-0426-2019

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.