FDA recall D-1587-2014

Product

NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502

Reason for recall

Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.

Distribution

TN, PA, and TX

Key facts

Status

Terminated

Initiation date

2013-04-17

Report date

2014-09-24

Termination date

2016-01-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Temple, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1587-2014