FDA-Drug2019-08-28Class II

Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.

SCA Pharmaceuticals, LLC
Hazard

Lack of Assurance of Sterility.

Sold states
Nationwide in the U.S.
Affected count
922 syringes
Manufactured in
755 Rainbow Rd Ste B, N/A, Windsor, CT, United States
Products
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1843-2019

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