Ranitidine hydrochloride recalled over manufacturing violations

Recall date

January 10, 2020

Source

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

Official notice title

PD-Rx Pharmaceuticals, Inc. recalls ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-8…

Recall number

D-0826-2020

FDA classification

Class II

Brand / firm

PD-Rx Pharmaceuticals, Inc.

Sold / distributed

AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN

Why it was recalled

CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

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

What was recalled

ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127