All Recalls

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

Labeling: Incorrect or missing package insert.

Incorrect labeling: Incorrect or missing lot and/or exp date

Lack of Sterility Assurance.

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.

Labeling: Incorrect or missing package insert.

Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Failed Dissolution Specification: Low out of specification dissolution results.

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Labeling: Incorrect or missing package insert.

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Lack of Sterility Assurance.

CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

Lack of Sterility Assurance.