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Class II: temporary or reversible health riskOngoing

Sanofi-Aventis U.S. Cool Mint Maximum Strength Zantac 150 mg Recall

Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc

Sanofi-Aventis U.S. LLC · Bridgewater, NJ

Risk level
Class II
Reported by FDA
Dec 11, 2019
Recall ID
D-0538-2020
Check your lot numberHow we source this data

Summary

Sanofi-Aventis U.S. recalled Cool Mint Maximum Strength Zantac 150 mg starting Oct 22, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0538-2020 on Dec 11, 2019. Reason: CGMP Deviations: Presence of NDMA impurity detected in product. Status: Ongoing.

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

Product description

Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7

Lot numbers, UPCs & expiration codes

all lots

Where it was sold

Nationwide

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-0538-2020
Classification
Class II
Status
Ongoing
Recall initiated
Oct 22, 2019
FDA report date
Dec 11, 2019
Recall type
Voluntary: Firm initiated
Recalling firm
Sanofi-Aventis U.S. LLC

Original FDA data

Every field from FDA enforcement report D-0538-2020, exactly as published.

Show all FDA fields
City
Bridgewater
State
NJ
Status
Ongoing
Country
United States
Event ID
84122
Address
55 Corporate Dr
Code information
all lots
Postal code
08807-1265
Report date
Dec 11, 2019
Product type
Drugs
Recall number
D-0538-2020
Classification
Class II
Recalling firm
Sanofi-Aventis U.S. LLC
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7
Distribution pattern
Nationwide
Recall initiation date
Oct 22, 2019
Initial firm notification
Letter
Center classification date
Dec 1, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0538-2020, published Dec 11, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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