June 2017 FDA Recall Drug by Sanofi-aventis U.s. Llc
D-0926-2017 - Superpotent Drug

This Class III drug recall was voluntarily initiated by Sanofi-aventis U.s. Llc on June 12, 2017 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0926-2017

Reason for Recall
Superpotent Drug: high out-of-specification result for magnesium.
Initiated
06-12-2017
Reported
07-05-2017
Quantity
2980 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77478
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sanofi-Aventis U.S. LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA, Puerto Rico, and the United Kingdom.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-07-2019
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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