Recalls / Class II

Class IID-0561-2024

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

Affected lot / code info

Lot #: 100047634 Exp. Date 4/2025; 35449379A, Exp. Date 7/2024

Why it was recalled

Subpotent Drug

Recalling firm

Firm

Teva Pharmaceuticals USA, Inc

Notification channel

N/A

Type

Voluntary: Firm initiated

Address

400 Interpace Pkwy Bldg A, N/A, Parsippany, New Jersey 07054-1120

Distribution

Quantity

34,448 bottles

Distribution pattern

Nationwide within the United States

Timeline

Recall initiated

2024-06-04

FDA classified

2024-06-18

Posted by FDA

2024-06-26

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0561-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.