Parsippany, NJ, United States
Reckitt Benckiser LLC recalls
3 recalls recorded since 2018, most recently on 19 December 2018. 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 Medical devices
- Recall started
- 19 December 2018
- Terminated
- 26 March 2021
- Reason
- Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
- Distribution
- Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0994-2019, Z-0993-2019
- Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00
- Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 0234
Terminated Class II Medical devices
- Recall started
- 6 August 2018
- Terminated
- 12 November 2019
- Reason
- Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
- Distribution
- US in the states of NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0091-2019
- Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseas
Terminated Class II Medical devices
- Recall started
- 23 July 2018
- Terminated
- 5 March 2020
- Reason
- The products failed the filed specification of 1.0kPa for Burst Pressure.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3241-2018
- Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic pu
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.