Status
Ongoing
Drug Enforcement D-0567-2023
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Classification
Class I
Report Date
May 17, 2023
Termination Date
—
Product Information
- 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.
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Camber Pharmaceuticals Inc.
- Address
-
800 Centennial Ave Ste 1, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0567-2023
- Event ID
- 91808
- Recall initiation date
- March 13, 2023
- Center classification date
- May 8, 2023
- Code info
- Lot# E220182, Exp. 12/31/2023
- More code info
- —