Med Shop Total Care product recalled over sterility concerns

Recall date

October 5, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Med Shop Total Care Inc. recalls HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b)…

Recall number

D-0711-2021

FDA classification

Class I

Brand / firm

Med Shop Total Care Inc.

Sold / distributed

Texas and Puerto Rico

Why it was recalled

Non-Sterility

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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