FDA-Drug2021-03-24Class II
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01.
Sagent Pharmaceuticals Inc
Hazard
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
3716 cartons
Manufactured in
1901 N Roselle Rd Ste 450, N/A, Schaumburg, IL, United States
Products
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0305-2021Don't want to check this manually?
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