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FDAFebruary 5, 2018drug

0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC

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

The hazard

Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.

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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