Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
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Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Dr. Reddy's Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Dr. Reddy's Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Dr. Reddy's Ranitidine Capsules
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets 75 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Dr. Reddy's: Ranitidine Capsules 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Children's Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Children's Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Children's Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class III · Low risk Terminated
Testosterone Cypionate Injection
Reason Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
Class II · Moderate risk Terminated
Estradiol tablets
Reason Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.