PharMEDium Services, LLC recalls 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium S
Recalled February 21, 2018 · FDA recall D-0423-2018 · PharMEDium Services
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. · FDA Class II
Units
21 Cassettes
Sold at
Product was distributed to SC, FL, NY, NY,WA
Description
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.
Product
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
Manufacturer(s)
PharMEDium Services, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →