Allergan recalls
Allergan appears in 33 official U.S. recall notices indexed by RecallRadar, most recently on 2021-02-10.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 33 |
|---|---|
| Published | 2015-07-15 to 2021-02-10 |
| By agency | FDA Device (24), FDA Drug (9) |
| By classification | Class I (16), Class II (10), Class III (7) |
| By status | ongoing (16), terminated (16), completed (1) |
| Distribution named in notices | AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, WA, WI, WY |
Recalls
- REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
FDA Device · Class II · 2021-02-10 · Allergan
Reason: Missing Instruction For Use insert. - Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ…
FDA Drug · Class II · 2021-01-27 · Allergan
Reason: Labeling: Missing instructions for use insert - Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4…
FDA Drug · Class III · 2020-08-05 · Allergan
Reason: SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. - Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz
FDA Drug · Class III · 2020-08-05 · Allergan
Reason: SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. - Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI:…
FDA Device · Class III · 2019-12-25 · Allergan
Reason: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data ch… - NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspir…
FDA Device · Class III · 2019-12-25 · Allergan
Reason: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data ch… - Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 75…
FDA Device · Class III · 2019-12-25 · Allergan
Reason: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data ch… - Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style…
FDA Device · Class III · 2019-12-25 · Allergan
Reason: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data ch… - XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439
FDA Device · Class II · 2019-12-11 · Allergan
Reason: Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to the patient's eye during procedure possib… - Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 1…
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast…
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Vari…
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: Breast augm…
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product U…
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstruction
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-…
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast reconstruction
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE…
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, i…
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infus…
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the follow…
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-…
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product Usag…
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and B…
FDA Device · Class I · 2019-09-18 · Allergan
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have text… - OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine…
FDA Drug · Class II · 2019-01-16 · Allergan
Reason: GMP Deviations: A silicone particulate was noted in Ozurdex. - INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheo…
FDA Drug · Class II · 2018-12-05 · Allergan
Reason: Failed Stability Specification: out of specification for iron content. - Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Allergan USA INC Irvi…
FDA Drug · Class I · 2018-06-20 · Allergan
Reason: Contraceptive Tablets Out of Sequence. - INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b)…
FDA Drug · Class II · 2018-03-07 · Allergan
Reason: Failed Stability Specifications: Product stability testing results did not meet specifications for iron content. - NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc.…
FDA Drug · Class III · 2018-02-21 · Allergan
Reason: Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label. - Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by
FDA Drug · Class II · 2018-01-17 · Allergan
Reason: Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile. - Natrelle CUI Series Tissue Expanders
FDA Device · Class II · 2015-07-29 · Allergan
Reason: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life. - Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation…
FDA Device · Class II · 2015-07-29 · Allergan
Reason: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life. - Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410
FDA Device · Class II · 2015-07-15 · Allergan
Reason: Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.