D-0561-2024 Class II Ongoing
FDA drug recall D-0561-2024 was initiated by Teva Pharmaceuticals USA, Inc on Jun 4, 2024 and is designated Class II. Reason for recall: Subpotent Drug The recall status is ongoing. Affected quantity: 34,448 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 26, 2024
- Initiation Date
- Jun 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,448 bottles
Product Description
Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34
Reason for Recall
Subpotent Drug
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 100047634 Exp. Date 4/2025; 35449379A, Exp. Date 7/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0561-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026