FDA Drug recall D-0772-2021
Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd
- FDA Drug
- Class I
- terminated
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class I recall of Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd by Kvk Tech, citing temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0772-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-07-02 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Kvk Tech |
| Distribution | US |
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
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Identifiers
| ndc | 10702-223-21 |
|---|---|
| code_info | Batch # 16653A, 16654A, Exp 12/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class I · 2023-10-25 · Kvk Tech - Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd
FDA Drug · Class III · 2021-05-26 · Kvk Tech - Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 US…
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0772-2021%22
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