FDA Recall D-0536-2020

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

Class II Ongoing 2396 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: all lots

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Recall record

Recall number: D-0536-2020
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2019-10-22
Classified by FDA Center: 2019-12-01
FDA published: 2019-12-11
Recalling firm: Sanofi-Aventis U.S. LLC
Firm location: Bridgewater, NJ

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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