D-601-2013 Class I Terminated
FDA drug recall D-601-2013 was initiated by Advance Pharmaceutical Inc on December 28, 2012 and is designated Class I. Reason for recall: Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness) The recall status is terminated (terminated June 29, 2016). Affected quantity: 19,944 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2013
- Initiation Date
- December 28, 2012
- Termination Date
- June 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,944 bottles
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)
Distribution Pattern
Nationwide
Code Information
Lot 12G468, Exp. 07/2014.