FDA-Drug2024-04-03Class II
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
SCA Pharmaceuticals, LLC
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide in the USA
Affected count
2,458, syringes
Manufactured in
755 Rainbow Rd Ste B, N/A, Windsor, CT, United States
Products
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0411-2024Don't want to check this manually?
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