FDA-Drug2018-07-11Class II

Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC
Hazard

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

Sold states
Product was distributed throughout the United States.
Affected count
179 bags
Manufactured in
755 Rainbow Rd Ste B, Windsor, CT, United States
Products
Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0896-2018

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