Atovaquone Oral Suspension USP recalled over sterility concerns

Recall date

March 13, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Camber Pharmaceuticals Inc. recalls Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc.,…

Recall number

D-0567-2023

FDA classification

Class I

Brand / firm

Camber Pharmaceuticals Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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.