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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88220

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

Open FDA event record

Event summary

Timeline bucket
July 02, 2021
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
KVK-Tech, 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

Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.

D-0772-2021
Recall number
D-0772-2021
Initiated
July 02, 2021
Classification
Class I
Status
Terminated
Recalling firm
KVK-Tech, Inc.
Quantity
1,692 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Temperature abuse: the firm received customer complaints of unusual grittiness in the product.

Code information

Batch # 16653A, 16654A, Exp 12/2022

Distribution pattern

Product was distributed to one distributor who may have further distributed Nationwide in the USA.