D-0459-2025 Class II Ongoing

Recalled by Alembic Pharmaceuticals Limited — Panchmahal

Recall Details

Product Type
Drugs
Report Date
June 18, 2025
Initiation Date
May 9, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,946 500-count bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

Distributed Nationwide and in PR

Code Information

Batch 2405014780, Exp. Date: Sep. 30, 2027