FDA-Drug2021-01-13Class II
fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016
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
2,834 syringes
Manufactured in
755 Rainbow Rd Ste B, Windsor, CT, United States
Products
fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0193-2021Don't want to check this manually?
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