Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200...
FDA Recall #D-136-2013 — Class III — December 18, 2012
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.
Reason for Recall
Defective Container: Product lacks tamper evident breakaway band on cap.
Recalling Firm
Belmora LLC — Arlington, VA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
17,996 bottles
Distribution
Nationwide
Code Information
Lot #: 1321, 1322, 1323, and 1324
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated