Drug Enforcement D-136-2013

Defective Container: Product lacks tamper evident breakaway band on cap.

Status

Terminated

Classification

Class III

Report Date

January 30, 2013

Termination Date

April 5, 2013

Product Information

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.
Product quantity
17,996 bottles
Reason for recall
Defective Container: Product lacks tamper evident breakaway band on cap.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Belmora LLC
Address
1805 Crystal Drive, Unit 303

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-136-2013
Event ID
64109
Recall initiation date
December 18, 2012
Center classification date
January 24, 2013
Code info
Lot #: 1321, 1322, 1323, and 1324
More code info