FDA recall D-0332-2015

Product

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-11-24

Report date

2015-01-14

Termination date

2017-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Spring Valley, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0332-2015