Why it was recalled
Defective Container: Product lacks tamper evident breakaway band on cap.
Product description
Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg, 12 fl oz (355 mL) bottles, Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203, UPC 8 53030 00209 0, NDC 27854.101.01.
Lot numbers, UPCs & expiration codes
Lot #: 1321, 1322, 1323, and 1324
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-136-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 18, 2012
- FDA report date
- Jan 30, 2013
- Quantity
- 17,996 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Belmora LLC
Original FDA data
Every field from FDA enforcement report D-136-2013, exactly as published.
Show all FDA fields
- City
- Arlington
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 64109
- Address
- 1805 Crystal Drive
- Address (line 2)
- Unit 303
- Code information
- Lot #: 1321, 1322, 1323, and 1324
- Postal code
- 22202
- Report date
- Jan 30, 2013
- Product type
- Drugs
- Recall number
- D-136-2013
- Classification
- Class III
- Recalling firm
- Belmora LLC
- Product quantity
- 17,996 bottles
- Termination date
- Apr 5, 2013
- Reason for recall
- Defective Container: Product lacks tamper evident breakaway band on cap.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg, 12 fl oz (355 mL) bottles, Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203, UPC 8 53030 00209 0, NDC 27854.101.01.
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 18, 2012
- Initial firm notification
- Letter
- Center classification date
- Jan 24, 2013