FDAClass IIJune 7, 2017

HYDROmorphone HCL in 0.9% Sodium Chloride injectable recall: Sterility Concern

HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg…

Why was HYDROmorphone HCL in 0.9% Sodium Chloride injectable recalled?

Lack of assurance of sterility: Product bags leaking at seam.

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 # 20170505@23, 20170505@28, Use By: 08/03/17

Product
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg…
Recalling firm
SCA Pharmaceuticals
Quantity
87 bags
Distribution
Nationwide in the USA
Recall date
June 7, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls