NORepinephrine 4 mg in recall: Sterility Concern
NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502
Why was NORepinephrine 4 mg in recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 00083844 Exp. 07/13
- 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
- Recalling firm
- Unique Pharmaceutical, Ltd
- Quantity
- 430 Bags
- Distribution
- TN, PA, and TX
- Recall date
- September 24, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)