Data Foundry

Drug recalls 2021

Atovaquone Oral Suspension — Class I drug recall D-0772-2021

Terminated recall by KVK-Tech, Inc., reported 2021-09-01, distributed nationwide. Temperature abuse: the firm received customer complaints of unusual grittiness in the product.

Recall numberD-0772-2021
Product typeDrug
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmKVK-Tech, Inc., Newtown, PA, United States
Recall initiated2021-07-02
Classified2021-08-26
Reported by FDA2021-09-01
Terminated2022-05-23
DistributedNationwide (US)
Quantity1,692 bottles
Reason classestemperature control
NDC10702-0223, 10702-0223-21
Lot numbers16653A, 16654A
Expiration dates2022-12

Product

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0772-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.