FDA-Drug2025-06-18Class II

Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71

Alembic Pharmaceuticals Limited
Hazard

Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule

Sold states
Distributed Nationwide and in PR
Affected count
2,946 500-count bottles
Manufactured in
Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, Panchmahal, India
Products
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0459-2025

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