FDAClass IIMarch 27, 2019

HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride recall: Sterility Concern

HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67…

Why was HYDROmorphone HCl 1 mg 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?

Lots: 12/03/18 4090 28967S Exp. 4/2/2019; 12/03/18 6221 28967S Exp. 4/2/2019

Product
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67…
Recalling firm
Advanced Pharma Inc.
Quantity
2400 syringes
Distribution
Nationwide
Recall date
March 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls