FDAClass IINovember 8, 2017

HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in recall: Sterility Concern

HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals…

Why was HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 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: 20170816@65 BUD: 10/30/2017

Product
HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals…
Recalling firm
SCA Pharmaceuticals, LLC
Quantity
60 bags
Distribution
Nationwide in the United States
Recall date
November 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls