💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
All Recalls
95,089 total recalls in our database
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
💊 Drugs Class I - Dangerous
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
💊 Drugs Class I - Dangerous
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
OOS for viscosity
Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-406-01
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
💊 Drugs Class I - Dangerous
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Golden State Medical Supply
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
💊 Drugs Class I - Dangerous
Failed Excipient Specifications: high content of ethylene glycol (EG)
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Bayer Healthcare Pharmaceuticals
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
💊 Drugs Class I - Dangerous
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Aizu Olympus Co.
🏥 Medical Devices Class I - Dangerous
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
🏥 Medical Devices Class I - Dangerous
Affected lots of product may experience technical distortions to a greater extent than expected.
🏥 Medical Devices Class I - Dangerous
It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.