Why it was recalled
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Product description
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.
Lot numbers, UPCs & expiration codes
Batch # 16653A, 16654A, Exp 12/2022
Where it was sold
Product was distributed to one distributor who may have further distributed Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0772-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 2, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 1,692 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KVK-Tech, Inc.
Original FDA data
Every field from FDA enforcement report D-0772-2021, exactly as published.
Show all FDA fields
- City
- Newtown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 88220
- Address
- 110 Terry Dr
- Code information
- Batch # 16653A, 16654A, Exp 12/2022
- Postal code
- 18940-3427
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0772-2021
- Classification
- Class I
- Recalling firm
- KVK-Tech, Inc.
- Product quantity
- 1,692 bottles
- Termination date
- May 23, 2022
- Reason for recall
- Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Product was distributed to one distributor who may have further distributed Nationwide in the USA.
- Recall initiation date
- Jul 2, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 26, 2021