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.
Reported: April 24, 2024 Initiated: March 28, 2024 #D-0444-2024
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.
Reason for Recall
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Details
- Recalling Firm
- AvKARE
- Units Affected
- 153 cartons
- Distribution
- US Nationwide.
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by AvKARE. Units affected: 153 cartons.
Why was this product recalled? ▼
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 24, 2024. Severity: Critical. Recall number: D-0444-2024.
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