FDA-Drug2021-01-13Class II

Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309

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
7,275 syringes
Manufactured in
755 Rainbow Rd Ste B, Windsor, CT, United States
Products
Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0200-2021

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