FDA Recall D-0772-2021
KVK-Tech, Inc. · Newtown, PA
Class I — life-threatening Terminated 325 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0772-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed to one distributor who may have further distributed Nationwide in the USA.
- Recall initiated
- 2021-07-02
- Classified by FDA Center
- 2021-08-26
- FDA published
- 2021-09-01
- Terminated
- 2022-05-23
- Recalling firm
- KVK-Tech, Inc.
- Firm location
- Newtown, PA
Drug identification
- Brand name(s)
- ATOVAQUONE ORAL SUSPENSION
- Generic name(s)
- ATOVAQUONE
- Manufacturer(s)
- KVK-Tech, Inc.
- NDC(s)
10702-223- Route(s)
- ORAL