FDA-Drug2014-09-24Class II

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

Unique Pharmaceutical, Ltd
Hazard

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.

Sold states
TN, PA, and TX
Affected count
430 Bags
Manufactured in
5920 S General Bruce Dr, Ste 100, Temple, TX, United States
Products
NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502

Official notice

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

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