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-
Recalled February 12, 2020 · FDA recall D-0826-2020 · PD-Rx Pharmaceuticals
Hazard
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels. · FDA Class II
Units
N/A
Sold at
AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN
Description
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Product
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
Manufacturer(s)
PD-Rx Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →