Exact FDA event identifier

Event 88309

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

Event summary

Timeline bucket: July 19, 2021
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

Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.

D-0750-2021

Recall number: D-0750-2021
Initiated: July 19, 2021
Classification: Class II
Status: Terminated
Recalling firm: Dr. Reddy's Laboratories, Inc.
Quantity: 37560 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Tablet/Capsule Specification: Some tablets are shaved

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specification: Some tablets are shaved

Code information

Lot #: T2000471, exp date 09/2023

Distribution pattern

Nationwide within the United States