HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharm...

FDA Recall #D-0332-2015 — Class II — November 24, 2014

Recall #D-0332-2015 Date: November 24, 2014 Classification: Class II Status: Terminated

Product Description

HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977

Reason for Recall

Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.

Recalling Firm

Par Pharmaceutical Inc. — Spring Valley, NY

Classification

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

Product Type

Drugs

Product Quantity

38,788 bottles

Distribution

Nationwide

Code Information

Lot 26708501, Exp. 01/17

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated