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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94329

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

Open FDA event record

Event summary

Timeline bucket
March 28, 2024
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
AvKARE

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

Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.

D-0444-2024
Recall number
D-0444-2024
Initiated
March 28, 2024
Classification
Class I
Status
Terminated
Recalling firm
AvKARE
Quantity
153 cartons

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.

Code information

Lot: AW0221A Exp. 08/30/2025

Distribution pattern

US Nationwide.