PharMEDium Services, LLC recalls Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland,…

Recall date

June 7, 2019

Source

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

Recall number

D-1488-2019

FDA classification

Class I

Brand / firm

PharMEDium Services, LLC

Sold / distributed

Nationwide within the United States

Why it was recalled

Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite

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 in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78