FDAClass IIFebruary 3, 2016

Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride recall

Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Why was Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride recalled?

Stability data does not support expiry.

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 lots with expiration dates up to 11/17/2015

Product
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Recalling firm
Pharmakon Pharmaceuticals
Quantity
8000
Distribution
Nationwide
Recall date
February 3, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls