FDA-Drug2021-01-13Class II
fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422
SCA Pharmaceuticals
Hazard
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Sold states
Product was distributed to hospitals nationwide.
Affected count
1,774 syringes
Manufactured in
755 Rainbow Rd Ste B, Windsor, CT, United States
Products
fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0191-2021Don't want to check this manually?
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