Why it was recalled
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot# E220182, Exp. 12/31/2023
Where it was sold
Nationwide in the USA
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-0567-2023
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Mar 13, 2023
- FDA report date
- May 17, 2023
- Quantity
- 1568 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Camber Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0567-2023, exactly as published.
Show all FDA fields
- City
- Piscataway
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 91808
- Address
- 800 Centennial Ave Ste 1
- Code information
- Lot# E220182, Exp. 12/31/2023
- Postal code
- 08854
- Report date
- May 17, 2023
- Product type
- Drugs
- Recall number
- D-0567-2023
- Classification
- Class I
- Recalling firm
- Camber Pharmaceuticals Inc.
- Product quantity
- 1568 bottles
- Reason for recall
- Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 13, 2023
- Initial firm notification
- Letter
- Center classification date
- May 8, 2023