Drug Enforcement D-0561-2024

Subpotent Drug

Status

Ongoing

Classification

Class II

Report Date

June 26, 2024

Termination Date

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Product Information

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
Product quantity
34,448 bottles
Reason for recall
Subpotent Drug
Recall initiation reason
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Initial firm notification
N/A
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Teva Pharmaceuticals USA, Inc
Address
400 Interpace Pkwy Bldg A, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0561-2024
Event ID
94750
Recall initiation date
June 4, 2024
Center classification date
June 18, 2024
Code info
Lot #: 100047634 Exp. Date 4/2025; 35449379A, Exp. Date 7/2024
More code info
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