FDAClass IIApril 3, 2024

HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride recall: Sterility Concern

HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755…

Why was HYDROmorphone HCl 25 mg/25 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?

Lot #: 1223048491 Exp 11/21/23

Product
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755…
Recalling firm
SCA Pharmaceuticals, LLC
Quantity
399 syringes
Distribution
Nationwide in the USA
Recall date
April 3, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls