Why it was recalled
Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
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
Lot numbers, UPCs & expiration codes
Lot 12G468, Exp. 07/2014.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-601-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 28, 2012
- FDA report date
- Jun 19, 2013
- Quantity
- 19,944 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advance Pharmaceutical Inc
Original FDA data
Every field from FDA enforcement report D-601-2013, exactly as published.
Show all FDA fields
- City
- Holtsville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 63988
- Address
- 895 Waverly Aveneue
- Code information
- Lot 12G468, Exp. 07/2014.
- Postal code
- 11742
- Report date
- Jun 19, 2013
- Product type
- Drugs
- Recall number
- D-601-2013
- Classification
- Class I
- Recalling firm
- Advance Pharmaceutical Inc
- Product quantity
- 19,944 bottles
- Termination date
- Jun 29, 2016
- Reason for recall
- Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 28, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 13, 2013