Allergan PLC

FDA Regulatory Profile

Summary

Total Recalls
33 (16 Class I)
510(k) Clearances
39
Inspections
6
Compliance Actions
0

Known Names

allergan, allergan sales, allergan industrie, allergan norden

Recent Recalls

NumberClassProductDate
D-0233-2021Class IIRefresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: December 30, 2020
Z-0948-2021Class IIREFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) SterileDecember 29, 2020
D-1409-2020Class IIISkin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. byJuly 6, 2020
D-1410-2020Class IIISkin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; PurifyingJuly 6, 2020
Z-0699-2020Class IIINatrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, StNovember 6, 2019
Z-0700-2020Class IIINatrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, StyNovember 6, 2019
Z-0701-2020Class IIINatrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608November 6, 2019
Z-0702-2020Class IIINATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gNovember 6, 2019
Z-0598-2020Class IIXEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5October 30, 2019
Z-2461-2019Class INatrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentationJuly 24, 2019
Z-2454-2019Class INatrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the July 24, 2019
Z-2452-2019Class INatrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height July 24, 2019
Z-2464-2019Class IRITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM ProdJuly 24, 2019
Z-2462-2019Class INatrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 SofJuly 24, 2019
Z-2465-2019Class INatrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast ImplaJuly 24, 2019
Z-2451-2019Class INatrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the followiJuly 24, 2019
Z-2458-2019Class IMcGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutJuly 24, 2019
Z-2463-2019Class IKomuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM July 24, 2019
Z-2455-2019Class INatrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site TiJuly 24, 2019
Z-2460-2019Class INatrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MFJuly 24, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K203229NATRELLE INSPIRA Single Use Sizers for Gel ImplantsJune 2, 2021
K193589TrueTear Intranasal Tear NeurostimulatorAugust 31, 2020
K190674REFRESH RELIEVA For CONTACTSAugust 8, 2019
K180826Natrelle 133 Plus MICROCELL Tissue ExpanderDecember 21, 2018
K182054Natrelle 133S Tissue ExpanderAugust 29, 2018
DEN170086TrueTear Intranasal Tear NeurostimulatorMay 17, 2018
K161457XEN Glaucoma Treatment SystemNovember 21, 2016
K143354Natrelle 133 Plus Tissue ExpanderAugust 20, 2015
K123128SERI SURGICAL SCAFFOLDApril 25, 2013
K083812REFRESH OPTIVE LENS COMFORT REWETTING DROPSJuly 9, 2009
K051852SINGLE AMPLIFIER FOR BOTOXSeptember 14, 2005
K014202COMPLETE BRAND MULTI-PURPOSE SOLUTIONFebruary 20, 2002
K013479COMPLETE BRAND MULTI-PURPOSE SOLUTIONFebruary 11, 2002
K003252COMPLETE BRAND MULTI-PURPOSE SOLUTIONFebruary 21, 2001
K003638MOJAVE CATARACT EXTRACTION SYSTEMFebruary 13, 2001
K003109COMPLETE BRAND LUBRICATING AND REWETTING DROPSNovember 21, 2000
K000164COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTIONJune 2, 2000
K992028REFRESH CONTACTS LUBRICATING AND REWETTING DROPSOctober 7, 1999
K984383ULTRACARE NEUTRALIZING TABLETSDecember 18, 1998
K983150COMPLETE BRAND LUBRICATING AND REWETTING DROPSNovember 25, 1998