Irvine, CA, United States
Allergan PLC recalls
12 recalls recorded since 2018, most recently on 30 December 2020. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)2
Terminated or completed10
Class I (FDA)2
Terminated Class II Drugs
- Recall started
- 30 December 2020
- Terminated
- 21 June 2023
- Reason
- Labeling: Missing instructions for use insert
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0233-2021
- Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10.
Terminated Class II Medical devices
- Recall started
- 29 December 2020
- Terminated
- 23 March 2023
- Reason
- Missing Instruction For Use insert.
- Distribution
- U.S.: MO O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0948-2021
- REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
Terminated Class III Drugs
- Recall started
- 6 July 2020
- Terminated
- 28 February 2024
- Reason
- SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1410-2020, D-1409-2020
- Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.
- Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02
Terminated Class III Medical devices
- Recall started
- 6 November 2019
- Terminated
- 9 July 2021
- 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 chain of the 2D barcode, which is not formatted to the GS1 standard.
- Distribution
- US: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,UT,VA,WA,WI,WY
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0700-2020, Z-0699-2020, Z-0701-2020, Z-0702-2020
- Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod 10888628001206, NATRELLE Style 10-210 G
- Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Style 68LP-150 Saline R
- Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 7629 SCF, 7630 SCX:
- NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), In
Ongoing Class II Medical devices
- Recall started
- 30 October 2019
- 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 possibly resulting in irritation, inflammation, local allergic reaction/ hypersensitivity, iritis, uveitis/sterile endophthalmitis or an intraocular foreign body.
- Distribution
- Worldwide distribution. US nationwide, countries of AE, AT, AU, BE, BG, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, IE, IL, IS, IT, KR, LT, MT, MU, MX, MY, NA, NL, NO, NZ, PH, PL, PT, RO, RS, SA, SE, SG, SI,SK, SM,TH,TR, TW, VE, and ZA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0598-2020
- XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.
Ongoing Class I Medical devices
- Recall started
- 24 July 2019
- 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 textured breast implants.
- Distribution
- Worldwide Distribution and US Nationwide All fifty (50) US States, the US Virgin Islands and Puerto Rico. (AK, AL, AR, AZ, CA, CO, CT, DC, DE, 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, RI, SC, SD, TN, TX, UT, VA, WA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2451-2019, Z-2456-2019, Z-2463-2019, Z-2465-2019, Z-2460-2019, Z-2453-2019, Z-2462-2019, Z-2458-2019, Z-2454-2019, Z-2457-2019, Z-2455-2019, Z-2452-2019 and 3 more
- Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style 168:168-120,168-150,168-1
- Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133P-FV: 133P-FV-11,
- Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction
- Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product Usage: Breast augmentation and Breast reconstruction
- Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: Breast augmentation and Breast reconstruction
- Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-410,TRL-460,TRL-510,TR
- Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product Usage : Breast augmentation and Breast reconstruction
- McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amou
- and 7 more product lines
Completed Class II Drugs
- Recall started
- 20 December 2018
- Reason
- GMP Deviations: A silicone particulate was noted in Ozurdex.
- Distribution
- Product was distributed to various accounts throughout the United States including VA and Government Accounts
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0387-2019
- OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07
Terminated Class II Drugs
- Recall started
- 8 November 2018
- Terminated
- 6 April 2020
- Reason
- Failed Stability Specification: out of specification for iron content.
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0282-2019
- 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 Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07
Terminated Class I Drugs
- Recall started
- 24 May 2018
- Terminated
- 19 May 2022
- Reason
- Contraceptive Tablets Out of Sequence.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0875-2018
- Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Allergan USA INC Irvine, CA 92612 NDC 0023-5862-28 (Blister Card) NDC 0023-5862-29 (Blister Carto
Terminated Class III Drugs
- Recall started
- 2 February 2018
- Terminated
- 7 February 2019
- Reason
- Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0413-2018
- NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.
Terminated Class II Drugs
- Recall started
- 13 December 2017
- Terminated
- 8 April 2020
- Reason
- Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
- Distribution
- Product was distributed nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0545-2018
- 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) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis
Terminated Class II Drugs
- Recall started
- 4 December 2017
- Terminated
- 20 June 2019
- Reason
- Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
- Distribution
- U.S.A. nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0154-2018
- Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.