December 2012 FDA Recall Drug by Advance Pharmaceutical Inc (D-601-2013 - Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness))

This Class I drug recall was voluntarily initiated by Advance Pharmaceutical Inc on December 28, 2012 for the product Drug. The FDA reported the reason for recall as labeling; label mixup; bottles of ferrous sulfate actually contains meclizine hcl (indicated for motion sickness). The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-601-2013

Reason for Recall
Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
Initiated
12-28-2012
Reported
06-19-2013
Quantity
19,944 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63988
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.
Advance Pharmaceutical 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-29-2016
Product Description About Product Description
Full technical description of the product.
Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013

Batch or Lot Expiration Information

Lot# Lot 12G468, Exp. 07/2014.