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.

FDA recall notice · announced March 24, 2021 · Sagent Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lots: PHT8IB2, PHT9IB2, exp 08/2022; PHT1JB2, exp 09/2022
Quantity: 3716 cartons
Status: Terminated
Products in this recall event:
- 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 (D-0305-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.