🍔 Food 💊 Drugs 🏥 Medical Devices
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, 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 63304-175-13. Class II

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

SUN PHARMACEUTICAL INDUSTRIES INC 20240118 Completed
Distributed: Nationwide in the USA
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Lurasidone Hydrochloride Tablets 120mg, 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 47335-579-83. Class II

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

SUN PHARMACEUTICAL INDUSTRIES INC 20240118 Completed
Distributed: Nationwide in the USA
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Lurasidone Hydrochloride Tablets 60mg, 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 47335-639-83. Class II

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

SUN PHARMACEUTICAL INDUSTRIES INC 20240118 Completed
Distributed: Nationwide in the USA
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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. Class II

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

SUN PHARMACEUTICAL INDUSTRIES INC 20240118 Completed
Distributed: Nationwide in the USA
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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. Class II

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

SUN PHARMACEUTICAL INDUSTRIES INC 20240118 Completed
Distributed: Nationwide in the USA
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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. Class II

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

SUN PHARMACEUTICAL INDUSTRIES INC 20240118 Completed
Distributed: Nationwide in the USA
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Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01. Class II

Reason: Lack of Sterility Assurance: Aseptic process simulation failure.

BE PHARMACEUTICALS AG 20240110 Terminated
Distributed: Nationwide in the USA
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Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18 Class I

Reason: Presence of particulate matter: glass

PFIZER 20231221 Ongoing
Distributed: Nationwide in the USA, Netherlands and Libya
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Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-752-16 Class II

Reason: Failed Dissolution Specifications

Strides Pharma Inc. 20231229 Terminated
Distributed: Nationwide in the USA
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Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56 Class II

Reason: Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

Glenmark Pharmaceuticals Inc., USA 20240104 Terminated
Distributed: USA Nationwide
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