Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride recall: Sterility Concern
Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON…
Why was Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 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
- Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON…
- Recalling firm
- Pharmakon Pharmaceuticals, Inc.
- Quantity
- 20
- Distribution
- Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
- Recall date
- July 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)