Home / Recalls / Sandoz, Inc / D-0128-2020

D-0128-2020 Class II Terminated

Recalled by Sandoz, Inc — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
October 16, 2019
Initiation Date
September 23, 2019
Termination Date
July 14, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,130 bottles

Product Description

Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05

Reason for Recall

CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

Distribution Pattern

U.S. Nationwide

Code Information

HD1862 4/30/2020 HP9438 9/30/2020 HP9439 9/30/2020 HP9440 9/30/2020

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