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Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL S...

FDA Recall #D-0305-2021 — Class II — March 11, 2021

Recall #D-0305-2021 Date: March 11, 2021 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

Sagent Pharmaceuticals Inc — Schaumburg, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3716 cartons

Distribution

Nationwide in the USA and Puerto Rico

Code Information

Lots: PHT8IB2, PHT9IB2, exp 08/2022; PHT1JB2, exp 09/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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