Multi-event January 2023 FDA Recall S2 by Nephron Sc Inc

This Multi-event Class II drug recall was voluntarily initiated by Nephron Sc Inc on January 13, 2023 for the product S2. The FDA reported the reason for recall as short fill. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0176-2023 TERMINATED D-0175-2023 TERMINATED

Recall Number: D-0176-2023

Reason for Recall
Short Fill
Initiated
01-13-2023
Reported
02-01-2023
Quantity
925,920 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91451
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.
Nephron Sc 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States including Puerto Rico. Guatamala
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-11-2024
Product Description About Product Description
Full technical description of the product.
S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9

Batch or Lot Expiration Information

Lot# : 126461, 126431 Exp. 04/30/2023

Affected Packages Involved in this Recall

0487-5901-99 S2

Recall Number: D-0175-2023

Reason for Recall
Short Fill
Initiated
01-13-2023
Reported
02-01-2023
Quantity
387,000 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91451
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.
Nephron Sc 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States including Puerto Rico. Guatamala
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-11-2024
Product Description About Product Description
Full technical description of the product.
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, NDC 0487-2784-01 UPC 3 04872 78401 4

Batch or Lot Expiration Information

Lot# : 126451 Exp. 04/30/2023