Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Ma...

FDA Recall #D-0188-2024 — Class II — January 26, 2022

Recall #D-0188-2024 Date: January 26, 2022 Classification: Class II Status: Terminated

Product Description

Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01

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

2 units

Distribution

Nationwide USA

Code Information

Batch Q101699, Q101981

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated