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Recall Observatory FDA recall evidence

Drug product

IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05

D-0047-2025

October 29, 2024

Class III

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 95620
Status
Ongoing
Classification
Class III
Quantity
3416 botttles
Official record key
drug-enforcement:D-0047-2025

Official wording

Reason: Failed Tablet/Capsule Specifications

Code information: Lot #: C5406201, Exp 03/31/2028

Distribution pattern: USA Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specifications