Sandoz product recalled over manufacturing violations

Recall date

September 23, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sandoz, Inc recalls Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of…

Recall number

D-0127-2020

FDA classification

Class II

Brand / firm

Sandoz, Inc

Sold / distributed

U.S. Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60