Why it was recalled
Superpotent Drug: high out-of-specification result for magnesium.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 5J69A, Exp 02/19; 6GF2A, 6GF3A, Exp 08/19
Where it was sold
Nationwide in the USA, Puerto Rico, and the United Kingdom.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0926-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 12, 2017
- FDA report date
- Jul 5, 2017
- Quantity
- 2980 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sanofi-Aventis U.S. LLC
Original FDA data
Every field from FDA enforcement report D-0926-2017, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77478
- Address
- 55 Corporate Dr
- Code information
- Lot #: 5J69A, Exp 02/19; 6GF2A, 6GF3A, Exp 08/19
- Postal code
- 08807-1265
- Report date
- Jul 5, 2017
- Product type
- Drugs
- Recall number
- D-0926-2017
- Classification
- Class III
- Recalling firm
- Sanofi-Aventis U.S. LLC
- Product quantity
- 2980 bottles
- Termination date
- Feb 7, 2019
- Reason for recall
- Superpotent Drug: high out-of-specification result for magnesium.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA, Puerto Rico, and the United Kingdom.
- Recall initiation date
- Jun 12, 2017
- Initial firm notification
- Letter
- Center classification date
- Jun 29, 2017