Why it was recalled
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Product description
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
Lot numbers, UPCs & expiration codes
Lot # 2310083, Exp. 09/30/2025
Where it was sold
Nationwide in the U.S.A.
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-0012-2025
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 17, 2024
- FDA report date
- Oct 23, 2024
- Quantity
- 1,980 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bionpharma Inc.
Original FDA data
Every field from FDA enforcement report D-0012-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 95345
- Address
- 400 Alexander Park Ste 2-4b
- Code information
- Lot # 2310083, Exp. 09/30/2025
- Postal code
- 08540-6539
- Report date
- Oct 23, 2024
- Product type
- Drugs
- Recall number
- D-0012-2025
- Classification
- Class I
- Recalling firm
- Bionpharma Inc.
- Product quantity
- 1,980 bottles
- Termination date
- Sep 16, 2025
- Reason for recall
- Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
- Distribution pattern
- Nationwide in the U.S.A.
- Recall initiation date
- Sep 17, 2024
- Initial firm notification
- Press Release
- Center classification date
- Oct 15, 2024