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HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10...

FDA Recall #D-0711-2021 — Class I — October 5, 2020

Recall #D-0711-2021 Date: October 5, 2020 Classification: Class I Status: Terminated

Product Description

HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Reason for Recall

Non-Sterility

Recalling Firm

Med Shop Total Care Inc. — Longview, TX

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

84 mL

Distribution

Texas and Puerto Rico

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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