# FDA recall D-0545-2020

> **Sanofi-Aventis U.S. LLC** · Class II · drug recall initiated 2019-10-22.

## Product

Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219.     NDC's  0597-0122-01	  0597-0122-08  0597-0122-13	  0597-0122-37	  0597-0122-40	  0597-0122-54	  0597-0122-61	  0597-0122-81	  0597-0122-96

## Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0545-2020
- **Recalling firm:** Sanofi-Aventis U.S. LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2019-10-22
- **Report date:** 2019-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bridgewater, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0545-2020

## Citation

> AI Analytics. FDA recall D-0545-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0545-2020. Source: US FDA. Licensed CC0.

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