Exact FDA event identifier

Event 92564

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

Event summary

Timeline bucket: June 21, 2023
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Dr Reddy's Laboratories Limited

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

Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10

D-0923-2023

Recall number: D-0923-2023
Initiated: June 21, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Dr Reddy's Laboratories Limited
Quantity: 17,548 1000-countbottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

Code information

Lot: T2100585, T2100586, T2100587, Exp 12/2023

Distribution pattern

Nationwide in the USA