Perrigo Company PLC Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg recall — FDA D-1023-2020
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
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CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count…
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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