Sandoz, Inc recalls Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Prod
Recalled October 16, 2019 · FDA recall D-0128-2020 · Sandoz
Hazard
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). · FDA Class II
Units
13,130 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 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05
Manufacturer(s)
Sandoz, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →