FDA recall D-136-2013

Belmora LLC · Class III · drug

Product

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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-12-18
Report date: 2013-01-30
Termination date: 2013-04-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Arlington, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-136-2013