Reckitt Benckiser LLC
FDA Regulatory Profile
Reckitt Benckiser LLC appears in FDA public data with 15 recalls — including 6 Class I (most serious) —, 9 510(k) clearances, 11 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0993-2019, Class II) was initiated on December 19, 2018. Its most recent 510(k) clearance was granted on January 12, 2018.
Summary
- Total Recalls
- 15 (6 Class I)
- 510(k) Clearances
- 9
- Inspections
- 11
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0993-2019 | Class II | Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456- | December 19, 2018 |
| Z-0994-2019 | Class II | Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 | December 19, 2018 |
| Z-0091-2019 | Class II | Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for co | August 6, 2018 |
| Z-3241-2018 | Class II | Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89 | July 23, 2018 |
| Z-1249-2017 | Class II | Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms | November 22, 2016 |
| D-1517-2016 | Class III | Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 3 | August 3, 2016 |
| D-1368-2015 | Class I | Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 | April 15, 2015 |
| D-1364-2015 | Class I | Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, | April 15, 2015 |
| D-1369-2015 | Class II | Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) | April 15, 2015 |
| D-1363-2015 | Class I | Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reduce | April 15, 2015 |
| D-1367-2015 | Class I | Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant | April 15, 2015 |
| D-1365-2015 | Class I | Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifene | April 15, 2015 |
| D-1366-2015 | Class I | Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bot | April 15, 2015 |
| D-0964-2015 | Class III | Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 t | November 10, 2014 |
| D-310-2013 | Class III | Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 | March 18, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K173504 | K-Y Silicone | January 12, 2018 |
| K151884 | K-Y Marilyn Pleasure Gel | January 11, 2016 |
| K143532 | Durex Silicone | July 31, 2015 |
| K143511 | K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant | May 20, 2015 |
| K131643 | DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT | December 17, 2014 |
| K140193 | DUREX EMBRACE PERSONAL LUBRICANT | November 4, 2014 |
| K990703 | SPOROX II STERILIZING & DISINFECTING SOLUTION | March 30, 1999 |
| K970230 | SPOROX | October 29, 1997 |
| K963353 | LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46) | October 18, 1996 |