Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharm...

FDA Recall #D-0201-2024 — Class II — January 26, 2022

Recall #D-0201-2024 Date: January 26, 2022 Classification: Class II Status: Terminated

Product Description

Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01

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

1 unit

Distribution

Nationwide USA

Code Information

Batch 2323041

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated