FDA Recall D-0561-2024
Teva Pharmaceuticals USA, Inc · Parsippany, NJ
Class II Ongoing 709 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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
Recall record
- Recall number
D-0561-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- N/A
- Distribution
- Nationwide within the United States
- Recall initiated
- 2024-06-04
- Classified by FDA Center
- 2024-06-18
- FDA published
- 2024-06-26
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Firm location
- Parsippany, NJ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.