Atovaquone Oral Suspension USP recall: Sterility Concern
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.
Why was Atovaquone Oral Suspension USP recalled?
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# E220182, Exp. 12/31/2023
- 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.
- Recalling firm
- Camber Pharmaceuticals Inc.
- Quantity
- 1568 bottles
- Distribution
- Nationwide in the USA
- Recall date
- May 17, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (drug)