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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83117

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

Open FDA event record

Event summary

Timeline bucket
June 12, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
InvaGen Pharmaceuticals, 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

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

Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: Cipla USA, Inc., Sunrise, FL 33323 NDC 69097-363-44

D-1454-2019
Recall number
D-1454-2019
Initiated
June 12, 2019
Classification
Class III
Status
Terminated
Quantity
1776 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container; actuator may improperly function and affect dose delivery.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container; actuator may improperly function and affect dose delivery.

Code information

Lot GH80480 and GH80481, exp 3/2020

Distribution pattern

Nationwide