Recalls / Class I
Class ID-0567-2023
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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.
- Brand name
- Atovaquone
- Generic name
- Atovaquone
- Active ingredient
- Atovaquone
- Route
- Oral
- NDC
- 31722-629
- FDA application
- ANDA210692
- Affected lot / code info
- Lot# E220182, Exp. 12/31/2023
Why it was recalled
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Recalling firm
- Firm
- Camber Pharmaceuticals Inc.
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 800 Centennial Ave Ste 1, N/A, Piscataway, New Jersey 08854
Distribution
- Quantity
- 1568 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-13
- FDA classified
- 2023-05-08
- Posted by FDA
- 2023-05-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0567-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.