Recalls / Class II

Class IID-0536-2020

Product

Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8

Affected lot / code info

all lots

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

Recalling firm

Firm

Sanofi-Aventis U.S. LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

55 Corporate Dr, Bridgewater, New Jersey 08807-1265

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2019-10-22

FDA classified

2019-12-01

Posted by FDA

2019-12-11

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0536-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.