March 2021 FDA Recall Phenylephrine Hydrochloride by Sagent Pharmaceuticals Inc
D-0305-2021 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Sagent Pharmaceuticals Inc on March 11, 2021 for the product Phenylephrine Hydrochloride. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0305-2021

Reason for Recall
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Initiated
03-11-2021
Reported
03-24-2021
Quantity
3716 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87492
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sagent Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2022
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

25021-315-01 Phenylephrine Hydrochloride
25021-315-99 Phenylephrine Hydrochloride
25021-315-98 Phenylephrine Hydrochloride