Reckitt Benckiser LLC

FDA Regulatory Profile

Summary

Total Recalls
15 (6 Class I)
510(k) Clearances
9
Inspections
10
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0993-2019Class IIDurex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-December 19, 2018
Z-0994-2019Class IIDurex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 December 19, 2018
Z-0091-2019Class IIPolyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for coAugust 6, 2018
Z-3241-2018Class IIDurex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89July 23, 2018
Z-1249-2017Class IIDurex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condomsNovember 22, 2016
D-1517-2016Class IIIMucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 3August 3, 2016
D-1369-2015Class IIMucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) April 15, 2015
D-1363-2015Class IMucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever ReduceApril 15, 2015
D-1368-2015Class IMucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6April 15, 2015
D-1367-2015Class IMucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough SuppressantApril 15, 2015
D-1366-2015Class IMucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) botApril 15, 2015
D-1364-2015Class IMucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer,April 15, 2015
D-1365-2015Class IMucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, GuaifeneApril 15, 2015
D-0964-2015Class IIIMucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tNovember 10, 2014
D-310-2013Class IIICherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16March 18, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K173504K-Y SiliconeJanuary 12, 2018
K151884K-Y Marilyn Pleasure GelJanuary 11, 2016
K143532Durex SiliconeJuly 31, 2015
K143511K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal LubricantMay 20, 2015
K131643DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANTDecember 17, 2014
K140193DUREX EMBRACE PERSONAL LUBRICANTNovember 4, 2014
K990703SPOROX II STERILIZING & DISINFECTING SOLUTIONMarch 30, 1999
K970230SPOROXOctober 29, 1997
K963353LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46)October 18, 1996