Exact FDA event identifier

Event 90702

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

Event summary

Timeline bucket: August 02, 2022
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: CIPLA

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

Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

D-1328-2022

Recall number: D-1328-2022
Initiated: August 02, 2022
Classification: Class II
Status: Terminated
Recalling firm: CIPLA
Quantity: 7,992 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Complaints received of defective container closure.

Code information

Lot # DEG3LC2, Exp 05/2023

Distribution pattern

Nationwide in the USA