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.
D-136-2013
Product summary
- Firm
- Belmora LLC
- Event
- Event 64109
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,996 bottles
- Official record key
drug-enforcement:D-136-2013
Official wording
Reason: Defective Container: Product lacks tamper evident breakaway band on cap.
Code information: Lot #: 1321, 1322, 1323, and 1324
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Defective Container: Product lacks tamper evident breakaway band on cap.