October 2014 FDA Recall Drug by Zee Medical Products Inc
D-0041-2015 - Incorrect/Undeclared Excipients

This Class II drug recall was voluntarily initiated by Zee Medical Products Inc on October 7, 2014 for the product Drug. The FDA reported the reason for recall as incorrect/undeclared excipients. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0041-2015

Reason for Recall
Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.
Initiated
10-07-2014
Reported
10-29-2014
Quantity
43,752 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69538
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.
Zee Medical Products 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.
04-24-2015
Product Description About Product Description
Full technical description of the product.
ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528

Batch or Lot Expiration Information

Lot# Lot No. AK5425, AK5172, AK5548, AK6047, AK6114, AK5865, AK5963, AK6175, AK6346, AK6438, AK7062