Phenylephrine Hydrochloride Injection, Solution
FDA Recall NDC 25021-315
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Phenylephrine Hydrochloride (NDC 25021-315). A significant event, classified as Class II, was initiated on Mar 11, 2021 by Sagent Pharmaceuticals. The reported reason for this action was: "Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Mar 11, 2021
Mar 24, 2021
3716 cartons
Recall Profile & Regulatory Data
Event ID
87492
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sagent Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Dec 28, 2022
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.
Batch or Lot Expiration Information
Lot# Lots: PHT8IB2, PHT9IB2, exp 08/2022; PHT1JB2, exp 09/2022
Affected Packages Involved in this Recall
25021-315-01Product
25021-315-99Product
25021-315-98Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
