ALLERGAN
ALLERGAN appears in FDA public data with 33 recalls — including 16 Class I (most serious) —, 39 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0233-2021, Class II) was initiated on December 30, 2020. Its most recent 510(k) clearance was granted on June 2, 2021.
Summary
- Total Recalls
- 33 (16 Class I)
- 510(k) Clearances
- 39
- Inspections
- 6
- Compliance Actions
- 0
Known Names
allergan, allergan industrie, allergan sales, allergan norden
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0233-2021 | Class II | Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: | December 30, 2020 |
| Z-0948-2021 | Class II | REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile | December 29, 2020 |
| D-1409-2020 | Class III | Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by | July 6, 2020 |
| D-1410-2020 | Class III | Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying | July 6, 2020 |
| Z-0701-2020 | Class III | Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 | November 6, 2019 |
| Z-0699-2020 | Class III | Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, St | November 6, 2019 |
| Z-0702-2020 | Class III | NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive g | November 6, 2019 |
| Z-0700-2020 | Class III | Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Sty | November 6, 2019 |
| Z-0598-2020 | Class II | XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5 | October 30, 2019 |
| Z-2454-2019 | Class I | Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the | July 24, 2019 |
| Z-2457-2019 | Class I | Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDE | July 24, 2019 |
| Z-2456-2019 | Class I | Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection w | July 24, 2019 |
| Z-2458-2019 | Class I | McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcut | July 24, 2019 |
| Z-2463-2019 | Class I | Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM | July 24, 2019 |
| Z-2455-2019 | Class I | Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Ti | July 24, 2019 |
| Z-2460-2019 | Class I | Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF | July 24, 2019 |
| Z-2461-2019 | Class I | Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation | July 24, 2019 |
| Z-2451-2019 | Class I | Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the followi | July 24, 2019 |
| Z-2453-2019 | Class I | Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Styl | July 24, 2019 |
| Z-2452-2019 | Class I | Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height | July 24, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants | June 2, 2021 |
| K193589 | TrueTear Intranasal Tear Neurostimulator | August 31, 2020 |
| K190674 | REFRESH RELIEVA For CONTACTS | August 8, 2019 |
| K180826 | Natrelle 133 Plus MICROCELL Tissue Expander | December 21, 2018 |
| K182054 | Natrelle 133S Tissue Expander | August 29, 2018 |
| DEN170086 | TrueTear Intranasal Tear Neurostimulator | May 17, 2018 |
| K161457 | XEN Glaucoma Treatment System | November 21, 2016 |
| K143354 | Natrelle 133 Plus Tissue Expander | August 20, 2015 |
| K123128 | SERI SURGICAL SCAFFOLD | April 25, 2013 |
| K083812 | REFRESH OPTIVE LENS COMFORT REWETTING DROPS | July 9, 2009 |
| K051852 | SINGLE AMPLIFIER FOR BOTOX | September 14, 2005 |
| K014202 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | February 20, 2002 |
| K013479 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | February 11, 2002 |
| K003252 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | February 21, 2001 |
| K003638 | MOJAVE CATARACT EXTRACTION SYSTEM | February 13, 2001 |
| K003109 | COMPLETE BRAND LUBRICATING AND REWETTING DROPS | November 21, 2000 |
| K000164 | COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION | June 2, 2000 |
| K992028 | REFRESH CONTACTS LUBRICATING AND REWETTING DROPS | October 7, 1999 |
| K984383 | ULTRACARE NEUTRALIZING TABLETS | December 18, 1998 |
| K983150 | COMPLETE BRAND LUBRICATING AND REWETTING DROPS | November 25, 1998 |