💊 Drugs Class I - Dangerous
cGMP deviations
All Recalls
95,075 total recalls in our database
CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.
KENIL HEALTHCARE PRIVATE LIMITED
💊 Drugs Class I - Dangerous
CGMP Deviations
KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.
KENIL HEALTHCARE PRIVATE LIMITED
💊 Drugs Class I - Dangerous
CGMP Deviations
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8 10096 77162 9.
KENIL HEALTHCARE PRIVATE LIMITED
💊 Drugs Class I - Dangerous
CGMP Deviations
KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3.
KENIL HEALTHCARE PRIVATE LIMITED
💊 Drugs Class I - Dangerous
CGMP Deviations
Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01
KENIL HEALTHCARE PRIVATE LIMITED
💊 Drugs Class I - Dangerous
CGMP Deviations
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.
KENIL HEALTHCARE PRIVATE LIMITED
💊 Drugs Class I - Dangerous
CGMP Deviations
🏥 Medical Devices Class I - Dangerous
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Cook Incorporated
🏥 Medical Devices Class I - Dangerous
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Centerline Biomedical
🏥 Medical Devices Class I - Dangerous
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Product Name: Ingenia 1.5T CX; Model Number: 781262;
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Cook Incorporated
🏥 Medical Devices Class I - Dangerous
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
🏥 Medical Devices Class I - Dangerous
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
🏥 Medical Devices Class I - Dangerous
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Smith & Nephew
🏥 Medical Devices Class I - Dangerous
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.