Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORA...
FDA Recall #D-601-2013 — Class I — December 28, 2012
Product Description
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
Reason for Recall
Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
Recalling Firm
Advance Pharmaceutical Inc — Holtsville, NY
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
19,944 bottles
Distribution
Nationwide
Code Information
Lot 12G468, Exp. 07/2014.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated