March 2016 FDA Recall Drug by Quva Pharma, Inc.
D-1066-2016 - Labeling

This Class I drug recall was voluntarily initiated by Quva Pharma, Inc. on March 30, 2016 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in CA and the recall is currently terminated.

Recall Number: D-1066-2016

Reason for Recall
Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.
Initiated
03-30-2016
Reported
07-13-2016
Quantity
20 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73710
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-29-2016
Product Description About Product Description
Full technical description of the product.
PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only, Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35.

Batch or Lot Expiration Information

Lot# : 14312-0, Exp 4/15/2016