CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Pis...

FDA Recall #D-0172-2024 — Class II — January 26, 2022

Recall #D-0172-2024 Date: January 26, 2022 Classification: Class II Status: Terminated

Product Description

CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC: 43598-719-10

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 2107329UM

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated