FDAFDA · Food and drugs·Recall number D-0567-2023
Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC# 31722-629-21.
Published May 17, 2023 · Recall initiated: March 13, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ATOVAQUONE
- Manufacturer
- Camber Pharmaceuticals Inc.
- Distributor
- Nationwide in the USA
- UPC
- 0331722629218
- Lot
- Lot# E220182, Exp. 12/31/2023
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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