Recalls / Class III
Class IIID-0926-2017
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.
- Affected lot / code info
- Lot #: 5J69A, Exp 02/19; 6GF2A, 6GF3A, Exp 08/19
Why it was recalled
Superpotent Drug: high out-of-specification result for magnesium.
Recalling firm
- Firm
- Sanofi-Aventis U.S. LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Corporate Dr, N/A, Bridgewater, New Jersey 08807-1265
Distribution
- Quantity
- 2980 bottles
- Distribution pattern
- Nationwide in the USA, Puerto Rico, and the United Kingdom.
Timeline
- Recall initiated
- 2017-06-12
- FDA classified
- 2017-06-29
- Posted by FDA
- 2017-07-05
- Terminated
- 2019-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0926-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.