D-1587-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 24, 2014
- Initiation Date
- April 17, 2013
- Termination Date
- January 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 430 Bags
Product Description
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 Pattern
TN, PA, and TX
Code Information
Lot # 00083844 Exp. 07/13