Recall Record

Skillman, NJ, United States

Johnson & Johnson Consumer, Inc. recalls

2 recalls recorded since 2018, most recently on 14 July 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)1

Ongoing Class I, Class II Drugs

Recall started
14 July 2021
Reason
cGMP Deviations
Distribution
Nationwide in US
Initiated
Voluntary: Firm initiated
Recall numbers
D-0843-2021, D-0833-2021, D-0849-2021, D-0836-2021, D-0834-2021, D-0841-2021, D-0842-2021, D-0832-2021, D-0838-2021, D-0837-2021, D-0848-2021, D-0846-2021 and 8 more

Terminated Class II Medical devices

Recall started
18 December 2017
Terminated
14 April 2020
Reason
Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH¿ Self-Adhering Sports Wraps, BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wraps and BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex.
Distribution
Nationally
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1201-2018, Z-1203-2018, Z-1206-2018, Z-1205-2018, Z-1202-2018, Z-1204-2018

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.