FDA-Drug2018-02-21Class II
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
PharMEDium Services, LLC
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.
Sold states
Product was distributed to SC, FL, NY, NY,WA
Affected count
21 Cassettes
Manufactured in
36 Stults Rd, Dayton, NJ, United States
Products
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0423-2018Don't want to check this manually?
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