Status
Terminated
Drug Enforcement D-601-2013
Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
Classification
Class I
Report Date
June 19, 2013
Termination Date
June 29, 2016
Product Information
- 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
- Product quantity
- 19,944 bottles
- Reason for recall
- Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Advance Pharmaceutical Inc
- Address
-
895 Waverly Aveneue, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-601-2013
- Event ID
- 63988
- Recall initiation date
- December 28, 2012
- Center classification date
- June 13, 2013
- Code info
- Lot 12G468, Exp. 07/2014.
- More code info
- —