The Recall Desk
LowFDA (Drugs)·D-0926-2017·Announced 2017-07-05

Gaviscon Chewable Tablets Recalled for High Magnesium Levels

Sanofi-Aventis is recalling Gaviscon chewable tablets due to high out-of-specification magnesium levels. The recall covers 2,980 bottles distributed in the US, Puerto Rico, and the UK.

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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Sanofi-Aventis U.S. LLC is recalling Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets. The recall involves 2,980 bottles of the 100-count product, distributed by GlaxoSmithKline Consumer Healthcare, L.P. The affected lots are 5J69A (Exp 02/19), 6GF2A, and 6GF3A (Exp 08/19).

The recall was initiated because the product produced a high out-of-specification result for magnesium. This is classified as a Superpotent Drug issue by the FDA. The agency has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The affected products were distributed nationwide in the USA, Puerto Rico, and the United Kingdom. Consumers should check their bottles for the specific lot numbers and expiration dates listed above. If they possess the affected product, they should stop using it and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8.
Manufacturer
Sanofi-Aventis U.S. LLC
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
2,980

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 (5)

  • Lot #: 5J69A
  • Exp 02/19
  • 6GF2A
  • 6GF3A
  • Exp 08/19

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

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