May 2014 FDA Recall Drug by Oasis Medical Inc
D-1347-2014 - Labeling

This Class III drug recall was voluntarily initiated by Oasis Medical Inc on May 14, 2014 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1347-2014

Reason for Recall
Labeling: Missing Label; The label on the immediate bottle is missing.
Initiated
05-14-2014
Reported
05-28-2014
Quantity
10,549 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68299
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-17-2014
Product Description About Product Description
Full technical description of the product.
Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 54819 00002 3.

Batch or Lot Expiration Information

Lot# : OTM-07, Expiry: 12/2015.