Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
Mylan Pharmaceuticals
Presence of particulate matter. presence of metal particles.
95,114 total recalls in our database
Mylan Pharmaceuticals
Presence of particulate matter. presence of metal particles.
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Defective Delivery System: Out of specification for mechanical peel and shear.
Perrigo Company PLC
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Fresenius Medical Care Holdings
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Sun Pharmaceutical Industries
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Perrigo Company PLC
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.
Perrigo Company PLC
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Perrigo Company PLC
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Strides Pharma Science Limited
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Defective Delivery System: Out of specification for mechanical peel and shear.
Defective Delivery System: Out of specification for mechanical peel and shear.
Sun Pharmaceutical Industries
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.