Teva Recalls Amoxicillin-Clavulanate Antibiotic Tablets Due to Subpotency
Teva Pharmaceuticals is recalling 34,448 bottles of Amoxicillin and Clavulanate Potassium Tablets USP (Chewable 400mg/57mg) distributed nationwide due to subpotency. The recall is voluntary and initiated by the firm.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II drug recall for subpotent Amoxicillin-Clavulanate tablets. While no illnesses or injuries are reported in the source, subpotent antibiotics pose a risk of treatment failure in patients depending on this medication's therapeutic efficacy.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg formulation, sold in 20-count bottles. The recall affects 34,448 bottles that were distributed nationwide throughout the United States.
The tablets have been found to be subpotent, meaning they contain less active pharmaceutical ingredient than intended. Subpotent antibiotics may not adequately treat bacterial infections as intended.
The affected lot numbers are 100047634 (expiration April 2025) and 35449379A (expiration July 2024). Patients taking this medication should consult their healthcare provider. The firm voluntarily initiated this recall on June 4, 2024.
The recalled product
- 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
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Antibiotic
- Hazard
- subpotency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 100047634 Exp. Date 4/2025
- 35449379A
- Exp. Date 7/2024
Distribution
Distributed nationwide across the United States.
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