Class I - Dangerous
CGMP Deviations: products may not conform to the labeled specifications.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class I - Dangerous
Presence of particulate matter: glass
Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 47335-721-83.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11
Amerisource Health Services
Class I - Dangerous
Superpotent drug: Assay results were slightly above specification at the time zero point.
Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
IntegraDose Compounding Services
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Lack of Sterility Assurance: Aseptic process simulation failure.
Class I - Dangerous
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol