AvKARE: Drug Recall

Recall #D-0444-2024 · 03/28/2024

Class I: Dangerous

Recall Details

Recall Number
D-0444-2024
Classification
Class I
Product Type
Drug
Recalling Firm
AvKARE
Status
Terminated
Date Initiated
03/28/2024
Location
Pulaski, TN, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
153 cartons

Reason for Recall

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

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.

Distribution Pattern

US Nationwide.

Other Recalls by AvKARE

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.