AbbVie

19 recalls •

💊 Drugs 🏥 Medical Devices

• Categories: Other Drugs, Prescription Drugs, Other Medical Devices

Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,

💊 Drugs Class I - Dangerous

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

Sep 16, 2024 Other Drugs Nationwide View Details →

Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042

💊 Drugs Class I - Dangerous

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

Sep 16, 2024 Other Drugs Nationwide View Details →

Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11

💊 Drugs Class I - Dangerous

Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.

Oct 17, 2023 Prescription Drugs View Details →

Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51

💊 Drugs Class I - Dangerous

Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.

Jan 22, 2018 Prescription Drugs View Details →

AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30

💊 Drugs Class I - Dangerous

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

Sep 8, 2017 Prescription Drugs View Details →

AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33

💊 Drugs Class I - Dangerous

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

Sep 8, 2017 Prescription Drugs View Details →

AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

🏥 Medical Devices Class I - Dangerous

PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.

Apr 27, 2017 Other Medical Devices Nationwide View Details →

AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

🏥 Medical Devices Class I - Dangerous

Apr 27, 2017 Other Medical Devices Nationwide View Details →

AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

🏥 Medical Devices Class I - Dangerous

PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.

Apr 27, 2017 Other Medical Devices Nationwide View Details →

Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., North Chicago, IL 60064 --- NDC 0074-3012-07

💊 Drugs Class I - Dangerous

Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life

Jan 13, 2017 Prescription Drugs View Details →

AbbVie PEG Kit 20 FR

🏥 Medical Devices Class I - Dangerous

AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.

Nov 22, 2016 Other Medical Devices View Details →

Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.

💊 Drugs Class I - Dangerous

Failed Content Uniformity Specifications

Mar 24, 2016 Prescription Drugs Nationwide View Details →

CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07.

💊 Drugs Class I - Dangerous

Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.

Sep 15, 2014 Prescription Drugs Nationwide View Details →

Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3346-03, UPC 3 00743 34603 9.

💊 Drugs Class I - Dangerous

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.