Drug Enforcement D-0459-2025

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

Status

Ongoing

Classification

Class II

Report Date

June 18, 2025

Termination Date

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Product Information

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
Product quantity
2,946 500-count bottles
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
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Distributed Nationwide and in PR

Location & Firm

Recalling firm
Alembic Pharmaceuticals Limited
Address
Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0459-2025
Event ID
96840
Recall initiation date
May 9, 2025
Center classification date
June 6, 2025
Code info
Batch 2405014780, Exp. Date: Sep. 30, 2027
More code info
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