💊 Drugs Class I - Dangerous
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
All Recalls
95,025 total recalls in our database
Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5
Bayer Healthcare Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7
Bayer Healthcare Pharmaceuticals
💊 Drugs Class I - Dangerous
Chemical Contamination: presence of benzene
Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86
Amneal Pharmaceuticals of New York
💊 Drugs Class I - Dangerous
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
🏥 Medical Devices Class I - Dangerous
Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.
🏥 Medical Devices Class I - Dangerous
There is a potential for distal tip dislodgement or separation.
🏥 Medical Devices Class I - Dangerous
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
REGARD Vitrectomy Tray
ROi CPS
🏥 Medical Devices Class I - Dangerous
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
REGARD Ear Tray
ROi CPS
🏥 Medical Devices Class I - Dangerous
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Due to a component in kit being labeled with the incorrect Expiration Date
🏥 Medical Devices Class I - Dangerous
A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was observed at creatinine levels up to 9,000 mg/L.
🏥 Medical Devices Class I - Dangerous
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
🏥 Medical Devices Class I - Dangerous
XXX
🏥 Medical Devices Class I - Dangerous
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
REGARD Basic Cataract tray
ROi CPS
🏥 Medical Devices Class I - Dangerous
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
🏥 Medical Devices Class I - Dangerous
There is a potential for distal tip dislodgement or separation.
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Medicalplastic S.R.L.
🏥 Medical Devices Class I - Dangerous
Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Tensioner has been made in a wrong plastic material that could wear and break during the sterilization process in autoclave. Consequently this could cause malfunctioning of the tensioner.
🏥 Medical Devices Class I - Dangerous
Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.
bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809
Beaver Visitec International
🏥 Medical Devices Class I - Dangerous
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades