AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc....

FDA Recall #D-0166-2024 — Class II — January 26, 2022

Recall #D-0166-2024 Date: January 26, 2022 Classification: Class II Status: Terminated

Product Description

AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20

Reason for Recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Recalling Firm

CARDINAL HEALTHCARE — Dublin, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2 units

Distribution

Nationwide USA

Code Information

Batch LJ9004

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated