NDC 17856-0631
Atovaquone 750 mg per 5 mL suspension
On the label: Atlantic Biologicals Corps.. It's repackaged: Atlantic Biologicals Corps. rebottles it from Camber Pharmaceuticals Inc.'s NDC 31722-629.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hetero Labs Limited | Hyderabad, India | Makes it | Problems found, fixed voluntarilyJul 21, 2023 · 8 inspections |
Recalls
- Mar 13, 2023 · Class I · Camber Pharmaceuticals Inc.
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Lots: Lot# E220182, Exp. 12/31/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Atovaquone: every company that makes it
- Form
- suspension, oral
- Strength
- 750 mg per 5 mL
- Approval
- ANDA ANDA210692
- On the market since
- Oct 11, 2018
- Package NDCs
17856-0631-117856-0631-2- Official label
- DailyMed (National Library of Medicine), updated May 12, 2025
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