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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78143

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 08, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
AbbVie 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

2 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 2

AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33

D-0033-2018
Recall number
D-0033-2018
Initiated
September 08, 2017
Classification
Class III
Status
Terminated
Recalling firm
AbbVie Inc.
Quantity
520 pumps

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

Code information

Lot: 91122, EXP. 01/2020

Distribution pattern

AZ

drug · product 2 of 2

AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30

D-0034-2018
Recall number
D-0034-2018
Initiated
September 08, 2017
Classification
Class III
Status
Terminated
Recalling firm
AbbVie Inc.
Quantity
48 cartons (30 foil packets per carton)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

Code information

Lot: D60010A, EXP. 01/2019

Distribution pattern

AZ