February 2019 FDA Recall Drug by Heritage Pharmaceuticals, Inc.
D-1065-2019 - Subpotent Drug.

This Class II drug recall was voluntarily initiated by Heritage Pharmaceuticals, Inc. on February 15, 2019 for the product Drug. The FDA reported the reason for recall as subpotent drug.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1065-2019

Reason for Recall
Subpotent Drug.
Initiated
02-15-2019
Reported
03-27-2019
Quantity
11888 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82198
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.
Heritage 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-04-2021
Product Description About Product Description
Full technical description of the product.
Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31

Batch or Lot Expiration Information

Lot# : AMA701, Exp. March 2019; AMA702, AMA703, Exp August 2019.