Reported Dec 11, 2019 · Ongoing
Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219,…
Sanofi-Aventis U.S. LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sanofi-Aventis U.S. LLC · 55 Corporate Dr · Bridgewater, NJ · 08807-1265
Is this the product you have?
- Cool Mint Tablets Maximum Strength
- Zantac 150 mg Sanofi Distributed byChattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
- NDC's
0597-0120-060597-0120-080597-0120-090597-0120-240597-0120-380597-0120-500597-0120-760597-0120-780597-0120-800597-0120-820597-0120-87
- Lot codes and dates
- all lots
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Sanofi-Aventis U.S. LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.