💊 Drugs Class I - Dangerous
CGMP Deviations
All Recalls
95,018 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations: Potential Glass and Silicone particulates in product
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1
Mallinckrodt Hospital Products
💊 Drugs Class I - Dangerous
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
💊 Drugs Class I - Dangerous
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Package Insert
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
💊 Drugs Class I - Dangerous
Chemical Contamination; presence of benzene.
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
Neptune Resources
💊 Drugs Class I - Dangerous
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
💊 Drugs Class I - Dangerous
CGMP Deviations: potential presence of Burkholderia cepacia complex
Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01
Henry Schein Inc. and Glove Club HSI Gloves
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specification: Out of specification for organic impurities
SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683
Today The World
💊 Drugs Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada
Today The World
💊 Drugs Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Cardinal Health 200
🏥 Medical Devices Class I - Dangerous
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
TRACH KIT W/HYDROGEN & SALI
Cardinal Health 200
🏥 Medical Devices Class I - Dangerous
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
🏥 Medical Devices Class I - Dangerous
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
🏥 Medical Devices Class I - Dangerous
Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.
🏥 Medical Devices Class I - Dangerous
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.