Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Product description
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.
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-0540-2020
- 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-0540-2020, 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-0540-2020
- 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
- Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 22, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 1, 2019