RecallRadar

FDA Drug recall D-1587-2014

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

On 2014-09-24 the FDA classified a Class II recall of NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502 by Unique Pharmaceutical, citing 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.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1587-2014
ClassificationClass II
Statusterminated
Initiated2013-04-17
Published2014-09-24
Last updated2026-09-13 11:51 UTC
CompanyUnique Pharmaceutical
DistributionPA, TN, TX

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

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.

Identifiers

code_infoLot # 00083844 Exp. 07/13

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1587-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.