FDA recall D-601-2013

Advance Pharmaceutical Inc · Class I · drug

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

Reason for recall

Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-12-28
Report date: 2013-06-19
Termination date: 2016-06-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Holtsville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-601-2013