The Recall Desk
LowFDA (Drugs)·D-136-2013·Announced 2013-01-30

Flanax Antacid Recalled for Missing Tamper-Evident Cap Band

Belmora LLC is recalling 17,996 bottles of Flanax antacid because the caps lack a tamper-evident breakaway band.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The defect is limited to packaging (missing tamper-evident band) with no reported injuries or illnesses.

Plain-English summary

Belmora LLC is recalling 17,996 bottles of Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid. The product is distributed in 12 fl oz (355 mL) bottles with NDC 27854.101.01 and UPC 8 53030 00209 0. The recall affects lots 1321, 1322, 1323, and 1324.

The recall was initiated because the product lacks a tamper-evident breakaway band on the cap. This defect is classified as a packaging issue by the U.S. Food and Drug Administration.

The affected product was distributed nationwide. Consumers should check their bottles for the missing breakaway band and contact the distributor for further instructions if the defect is present.

The recalled product

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.
Manufacturer
Belmora LLC
Category
Drug — Antacid
Hazard
Affected units
17,996

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: 1321
  • 1322
  • 1323
  • and 1324

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · packaging defect

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