Atovaquone Oral Suspension USP recall: Sterility Concern
Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC…
Why was Atovaquone Oral Suspension USP recalled?
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
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?
Lot: AW0221A Exp. 08/30/2025
- Product
- Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC…
- Recalling firm
- AvKARE
- Quantity
- 153 cartons
- Distribution
- US Nationwide.
- Recall date
- April 24, 2024
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)