Class II
Terminated
NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502
This recall has been terminated (originally issued September 24, 2014).
- Company
- Unique Pharmaceutical, Ltd
- Recall Initiated
- April 17, 2013
- Posted
- September 24, 2014
- Recall Number
- D-1587-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 430 Bags
- Firm Location
- Temple, TX, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot # 00083844 Exp. 07/13
More recalls by Unique Pharmaceutical, Ltd
All sterile products within expiry
Oct 15, 2014 · Class II
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