Why it was recalled
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Product description
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 50268-086-12.
Lot numbers, UPCs & expiration codes
Lot: AW0221A Exp. 08/30/2025
Where it was sold
US Nationwide.
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-0444-2024
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 28, 2024
- FDA report date
- Apr 24, 2024
- Quantity
- 153 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AvKARE
Original FDA data
Every field from FDA enforcement report D-0444-2024, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 94329
- Address
- 615 N 1st St
- Code information
- Lot: AW0221A Exp. 08/30/2025
- Postal code
- 38478-2403
- Report date
- Apr 24, 2024
- Product type
- Drugs
- Recall number
- D-0444-2024
- Classification
- Class I
- Recalling firm
- AvKARE
- Product quantity
- 153 cartons
- Termination date
- Aug 23, 2024
- Reason for recall
- Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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 50268-086-12.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Mar 28, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 16, 2024