AbbVie Inc.
Summary
- Total Recalls
- 19
- 510(k) Clearances
- 7
- Inspections
- 47
- Compliance Actions
- 0
Known Names
abbvie-ireland-nl-b-v, abbvie-deutschland-gmbh-co-kg, abbvie ireland nl b v, abbvie, abbvie deutschland gmbh co kg, abbvie-medical-device-center, abbvie-srl, abbvie-biotechnology, abbvie-logistics-bv, abbvie-us
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0664-2024 | Class II | Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3 | September 16, 2024 |
| D-0665-2024 | Class II | Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 | September 16, 2024 |
| D-0088-2024 | Class III | Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. | October 17, 2023 |
| D-0412-2018 | Class III | Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North C | January 22, 2018 |
| D-0033-2018 | Class III | AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuat | September 8, 2017 |
| D-0034-2018 | Class III | AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx On | September 8, 2017 |
| Z-2177-2017 | Class II | AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | April 27, 2017 |
| Z-2176-2017 | Class II | AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | April 27, 2017 |
| Z-2178-2017 | Class II | AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | April 27, 2017 |
| D-0495-2017 | Class II | Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassette | January 13, 2017 |
| Z-0786-2017 | Class II | AbbVie PEG Kit 20 FR | November 22, 2016 |
| D-0833-2016 | Class III | Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, | March 24, 2016 |
| D-1611-2014 | Class II | CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only | September 15, 2014 |
| D-1289-2014 | Class II | LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefi | March 10, 2014 |
| D-1287-2014 | Class II | Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled | March 10, 2014 |
| D-1288-2014 | Class II | Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled | March 10, 2014 |
| D-1291-2014 | Class II | Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled | March 10, 2014 |
| D-1290-2014 | Class II | Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled | March 10, 2014 |
| D-901-2013 | Class III | Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc | August 1, 2013 |