FDA recall D-0826-2020

PD-Rx Pharmaceuticals, Inc. · Class II · drug

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

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2020-01-10
Report date: 2020-02-12
Termination date: 2021-03-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Oklahoma City, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0826-2020