PharMEDium Services, LLC. recalls Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Serv…

Recall date

October 13, 2017

Source

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

Recall number

D-0080-2018

FDA classification

Class II

Brand / firm

PharMEDium Services, LLC.

Sold / distributed

CA, IL

Why it was recalled

Superpotent drug: out of specification result for potency

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40