← FDA ENFORCEMENT
D-0561-2024Class II

Teva Pharmaceuticals USA, Inc

Recalling firm
Teva Pharmaceuticals USA, Inc
Product type
Drug
Status
Ongoing
Report date
2024-06-26
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
34,448 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Subpotent Drug

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

Code / lot info

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

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.