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FDAJuly 21, 2015drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

pharmedium servicespharmedium

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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