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Recall Observatory FDA recall evidence

Drug product

Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10

D-0541-2024

May 16, 2024

Class III

Product summary

Firm
Rising Pharma Holding, Inc.
Event
Event 94642
Status
Ongoing
Classification
Class III
Quantity
N/A
Official record key
drug-enforcement:D-0541-2024

Official wording

Reason: Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.

Code information: Lot: 23132611, Exp 07/31/2026

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets