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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86940

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

Open FDA event record

Event summary

Timeline bucket
December 07, 2020
Product types
Drug
Classifications
Class I and Class II
Statuses
Terminated
Recalling firm wording
AVKARE 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

Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.

D-0167-2021
Recall number
D-0167-2021
Initiated
December 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
AVKARE Inc.
Quantity
38715 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

Code information

Lot: 36884 Exp. 03/2022

Distribution pattern

Nationwide within the U.S.

drug · product 2 of 2

TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10

D-0168-2021
Recall number
D-0168-2021
Initiated
December 07, 2020
Classification
Class I
Status
Terminated
Recalling firm
AVKARE Inc.
Quantity
14368 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

Code information

Lot: 36783 Exp. 06/2022

Distribution pattern

Nationwide within the U.S.