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 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Prod…

Recall number

D-0129-2020

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 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31