PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadist...

FDA Recall #D-0193-2024 — Class II — January 26, 2022

Recall #D-0193-2024 Date: January 26, 2022 Classification: Class II Status: Terminated

Product Description

PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06

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 21P0659

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated