May 2020 FDA Recall Drug by Quva Pharma, Inc.
D-1302-2020 - Subpotent drug - Product did not contain drug.

This Class II drug recall was voluntarily initiated by Quva Pharma, Inc. on May 28, 2020 for the product Drug. The FDA reported the reason for recall as subpotent drug - product did not contain drug.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1302-2020

Reason for Recall
Subpotent drug - Product did not contain drug.
Initiated
05-28-2020
Reported
06-17-2020
Quantity
648 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85773
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.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-19-2022
Product Description About Product Description
Full technical description of the product.
oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07

Batch or Lot Expiration Information

Lot# : 30010515