Sandoz, Inc recalls Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of
Recalled October 16, 2019 · FDA recall D-0127-2020 · Sandoz
Hazard
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). · FDA Class II
Units
100,314 bottles
Sold at
U.S. Nationwide
Description
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Product
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
Manufacturer(s)
Sandoz, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →