Drug Enforcement D-0444-2024

Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.

Status

Terminated

Classification

Class I

Report Date

April 24, 2024

Termination Date

August 23, 2024

Product Information

Product description
Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.
Product quantity
153 cartons
Reason for recall
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
US Nationwide.

Location & Firm

Recalling firm
AvKARE
Address
615 N 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0444-2024
Event ID
94329
Recall initiation date
March 28, 2024
Center classification date
April 16, 2024
Code info
Lot: AW0221A Exp. 08/30/2025
More code info
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