# FDA recall D-0772-2021

> **KVK-Tech, Inc.** · Class I · drug recall initiated 2021-07-02.

## 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.

## Distribution

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

## Key facts

- **Recall number:** D-0772-2021
- **Recalling firm:** KVK-Tech, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-07-02
- **Report date:** 2021-09-01
- **Termination date:** 2022-05-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newtown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0772-2021

## Citation

> AI Analytics. FDA recall D-0772-2021. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-0772-2021. Source: US FDA. Licensed CC0.

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