August 2018 FDA Recall Drug by Quva Pharma, Inc.
D-0003-2019 - Subpotent Drug

This Class I drug recall was voluntarily initiated by Quva Pharma, Inc. on August 27, 2018 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-0003-2019

Reason for Recall
Subpotent Drug: Product may not have the active ingredient present in the bag.
Initiated
08-27-2018
Reported
09-26-2018
Quantity
528 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80980
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
QuVa Pharma, 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 to hospitals in USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-02-2019
Product Description About Product Description
Full technical description of the product.
Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.

Batch or Lot Expiration Information

Lot# :30000271, Exp 10/1/18