October 2019 FDA Recall Drug by Nephron Pharmaceuticals Corporation Dba Nephron Sterile Compounding Center
D-0154-2020 - Incorrect labeling

This Class III drug recall was voluntarily initiated by Nephron Pharmaceuticals Corporation Dba Nephron Sterile Compounding Center on October 21, 2019 for the product Drug. The FDA reported the reason for recall as incorrect labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0154-2020

Reason for Recall
Incorrect labeling: Incorrect or missing lot and/or exp date
Initiated
10-21-2019
Reported
11-06-2019
Quantity
19,390 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84106
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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 Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
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 in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2020
Product Description About Product Description
Full technical description of the product.
PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.

Batch or Lot Expiration Information

Lot# Lots: SU9079A, SU9079B, Exp 4/5/2020