FDA Recall D-601-2013
Advance Pharmaceutical Inc · Holtsville, NY
Class I — life-threatening Terminated 1279 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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)
Recall record
- Recall number
D-601-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide
- Recall initiated
- 2012-12-28
- Classified by FDA Center
- 2013-06-13
- FDA published
- 2013-06-19
- Terminated
- 2016-06-29
- Recalling firm
- Advance Pharmaceutical Inc
- Firm location
- Holtsville, NY