Drug 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
D-1587-2014
Product summary
- Event
- Event 67904
- Status
- Terminated
- Classification
- Class II
- Quantity
- 430 Bags
- Official record key
drug-enforcement:D-1587-2014
Official wording
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.
Code information: Lot # 00083844 Exp. 07/13
Distribution pattern: TN, PA, and TX
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility