FDA Recall D-0567-2023

Camber Pharmaceuticals Inc. · Piscataway, NJ

Class I — life-threatening Ongoing 1158 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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.

Lot / code: Lot# E220182, Exp. 12/31/2023

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 record

Recall number: D-0567-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2023-03-13
Classified by FDA Center: 2023-05-08
FDA published: 2023-05-17
Recalling firm: Camber Pharmaceuticals Inc.
Firm location: Piscataway, NJ

Drug identification

Brand name(s): ATOVAQUONE
Generic name(s): ATOVAQUONE
Manufacturer(s): Camber Pharmaceuticals, Inc.
NDC(s): 31722-629
Route(s): ORAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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