FDAFDA · Food and drugs·Recall number 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
Published September 24, 2014 · Recall initiated: April 17, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Unique Pharmaceutical, Ltd
- Distributor
- TN, PA, and TX
- Lot
- Lot # 00083844 Exp. 07/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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