Class I - Dangerous
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-51
Perrigo Company PLC
Class I - Dangerous
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class I - Dangerous
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class I - Dangerous
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class I - Dangerous
Defective Delivery System: Out of specification for mechanical peel and shear.
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75
Perrigo Company PLC
Class I - Dangerous
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class I - Dangerous
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05
Sun Pharmaceutical Industries
Class I - Dangerous
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
American Health Packaging
Class I - Dangerous
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Class I - Dangerous
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class I - Dangerous
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class I - Dangerous
Product Mix-Up: A foreign tablet was found in bottle.
Class I - Dangerous
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class I - Dangerous
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 bottle
Class I - Dangerous
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class I - Dangerous
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Class I - Dangerous
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.