April 2015 FDA Recall Drug by Oasis Medical, Inc.
D-1084-2015 - Failed pH specification

This Class III drug recall was voluntarily initiated by Oasis Medical, Inc. on April 10, 2015 for the product Drug. The FDA reported the reason for recall as failed ph specification. The product was distributed in FL and the recall is currently terminated.

Recall Number: D-1084-2015

Reason for Recall
Failed pH specification
Initiated
04-10-2015
Reported
05-27-2015
Quantity
9,731 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71152
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.
Oasis Medical, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2015
Product Description About Product Description
Full technical description of the product.
ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05

Batch or Lot Expiration Information

Lot# V0814B, Exp 02/16; V1014H, Exp 04/16