FDA-Drug2020-02-12Class II
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
PD-Rx Pharmaceuticals, Inc.
Hazard
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Sold states
AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN
Affected count
N/A
Manufactured in
727 N Ann Arbor Ave, N/A, Oklahoma City, OK, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0826-2020Don't want to check this manually?
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