Ropivacaine HCl 0 recalled over sterility concerns

Recall date

July 21, 2015

Source

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

Official notice title

Pharmedium Services, LLC recalls Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only,…

Recall number

D-1428-2015

FDA classification

Class II

Brand / firm

Pharmedium Services, LLC

Sold / distributed

VA, IL, PA, ID

Why it was recalled

Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.

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

What was recalled

Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48