Atovaquone Oral Suspension recall
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.
Why was Atovaquone Oral Suspension recalled?
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch # 16653A, 16654A, Exp 12/2022
- 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.
- Recalling firm
- KVK-Tech, Inc.
- Quantity
- 1,692 bottles
- Distribution
- Product was distributed to one distributor who may have further distributed Nationwide in the USA.
- Recall date
- September 1, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)