Exact FDA event identifier

Event 66117

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: August 29, 2013
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Dr. Reddy's Laboratories, Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA.

D-1042-2013

Recall number: D-1042-2013
Initiated: August 29, 2013
Classification: Class II
Status: Terminated
Recalling firm: Dr. Reddy's Laboratories, Inc.
Quantity: 18852 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect or missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.

Code information

Lot # L300192; Exp. 05/2017

Distribution pattern

Nationwide (& Puerto Rico)