Succinylcholine Chloride recalled over sterility concerns

Recall date

October 12, 2016

Source

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

Official notice title

Pharmedium Services, LLC recalls Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN,…

Recall number

D-0125-2017

FDA classification

Class II

Brand / firm

Pharmedium Services, LLC

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.

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

What was recalled

Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.