Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc.,
Summary
The FDA issued a Class I for Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufact by Camber Pharmaceuticals Inc.. Reason: Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged p.
Details
Source
Drug Recall
External ID
D-0567-2023
Action Date
2023-05-17
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot# E220182, Exp. 12/31/2023
Quantity Affected: 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.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-13
Company
Piscataway, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 27 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Camber Pharmaceuticals Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Camber Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Camber Pharmaceuticals Inc. have FDA actions?
Camber Pharmaceuticals Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0567-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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