FDA-Drug2019-10-09Class II
Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419
KRS Global Biotechnology, Inc
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide
Affected count
6405 syringes
Manufactured in
791 Park of Commerce Blvd Ste 600, N/A, Boca Raton, FL, United States
Products
Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0066-2020Don't want to check this manually?
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