Home / Recalls / Sanofi-Aventis U.S. LLC / D-0544-2020

D-0544-2020 Class II Ongoing

Recalled by Sanofi-Aventis U.S. LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
December 11, 2019
Initiation Date
October 22, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8

Reason for Recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution Pattern

Nationwide

Code Information

all lots

Other recalls by Sanofi-Aventis U.S. LLC

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  • D-0538-2020 Class II — Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanof (October 22, 2019)
  • D-0534-2020 Class II — Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, (October 22, 2019)
  • D-0540-2020 Class II — Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P (October 22, 2019)
  • D-0535-2020 Class II — Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P (October 22, 2019)
  • D-0539-2020 Class II — Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company (October 22, 2019)
  • D-0537-2020 Class II — Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P (October 22, 2019)
  • D-0545-2020 Class II — Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Cha (October 22, 2019)
  • D-0541-2020 Class II — Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company (October 22, 2019)