FDAClass IAugust 18, 2021

Hydromorphone Hcl-bupivacaine Hcl-fentanyl PF recall: Sterility Concern

HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c)…

Why was Hydromorphone Hcl-bupivacaine Hcl-fentanyl PF recalled?

Non-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 #: a) 09282020@66, BUD 10/27/2020, 09302020@42, BUD 10/29/2020, b) 09282020@79, c) 09292020@32, BUD 10/27/2020 09282020@66 09302020@42 09282020@79 09292020@32 10/27/2020 10/29/2020 10/27/2020 10/27/2020

Product
HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c)…
Recalling firm
Med Shop Total Care Inc.
Quantity
84 mL
Distribution
Texas and Puerto Rico
Recall date
August 18, 2021
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls