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.
Reported: May 17, 2023 Initiated: March 13, 2023 #D-0567-2023
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.
Reason for Recall
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Details
- Recalling Firm
- Camber Pharmaceuticals Inc.
- Units Affected
- 1568 bottles
- Distribution
- Nationwide in the USA
- Location
- Piscataway, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Camber Pharmaceuticals Inc.. Units affected: 1568 bottles.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 17, 2023. Severity: Critical. Recall number: D-0567-2023.
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