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Mesalamine Capsules (Sun Pharmaceutical) – Dissolution Failure (2024)

Failed Dissolution Specifications: Out of specification for dissolution.

FDAFeb 5, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Lansoprazole Capsules (NATCO Pharma) – Inadequate Sealing (2024)

CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

Class IIModerate

FDAFeb 1, 2024Nationwide• NATCO Pharma Limited

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Mesalamine Capsules (Sun Pharmaceutical) – Dissolution Failure (2024)

Lansoprazole Capsules (NATCO Pharma) – Inadequate Sealing (2024)

To the Moon Capsules (Integrity) – Undeclared Sildenafil (2024)

RAM IT Horny Goat Weed Capsules (Integrity) – Undeclared Sildenafil (2024)

HydrALAZINE Tablets (Amerisource) – Impurities Specification (2024)

Lubricant PM Ointment (Brassica) – Sterility Concern (2024)

Equate Eye Ointment (Brassica) – Sterility Concern (2024)

Equate Stye Eye Ointment (Brassica) – Sterility Concern (2024)

CVS Health Eye Ointment (Brassica) – Sterility Concern (2024)

Nortrel 7/7/7 Tablets (Teva) – Tablet Discoloration (2024)

Nortrel Tablets (Teva) – Tablet Discoloration (2024)

Norepinephrine Injection (Baxter) – Label Concentration Error (2024)

Vasopressin Injection (IntegraDose) – Sub-potent Drug (2024)

Glimepiride Tablets 1mg (Dr. Reddy's) – Tablet Misprint (2024)

Glimepiride Tablets 1mg 500-count (Dr. Reddy's) – Tablet Misprint (2024)

Fosfomycin Tromethamine Granules (Ascend) – Impurity Specification (2024)

Vasopressin Sodium Chloride (IntegraDose) – Subpotent Drug (2024)

Vasostrict (Par Sterile Products) – Superpotent Drug (2024)

Budesonide Tablets (Teva) – Failed Dissolution (2024)

Bupropion XL Tablets (Rising Pharma) – Foreign Tablets (2023)