Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% recall: Sterility Concern
Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals…
Why was Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% recalled?
Lack of Assurance of Sterility
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?
All Sterile Compounded Products within Expiry
- Product
- Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals…
- Recalling firm
- Pharmakon Pharmaceuticals, Inc.
- Quantity
- 150 bags
- Distribution
- Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
- Recall date
- July 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)