Exact FDA event identifier

Event 81795

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

Event summary

Timeline bucket: December 14, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Cipla 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

Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02

D-0382-2019

Recall number: D-0382-2019
Initiated: December 14, 2018
Classification: Class II
Status: Terminated
Recalling firm: Cipla Limited
Quantity: 4800 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications.

Code information

Lot #: GG80257, Exp. 12/2019

Distribution pattern

Nationwide within the United States