FDA-Drug2021-01-13Class III

Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025

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
751 syringes
Manufactured in
755 Rainbow Rd Ste B, Windsor, CT, United States
Products
Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0201-2021

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