Reported Feb 12, 2020 · Terminated
ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC…
PD-Rx Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PD-Rx Pharmaceuticals, Inc. · 727 N Ann Arbor Ave · Oklahoma City, OK · 73127-5822
Is this the product you have?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | 14-count bottles ( NDC 43063-844-14) |
| 2 | 30-count bottles (NDC 43063-844-30) |
| 3 | 60 -count bottles( NDC 43063-844-60) |
| 4 | 90-count bottles (NDC 43063-844-90) |
| 5 | 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 H19E83 Exp. 11/30/2020, E19A82 Exp. 05/31/2020 2 H19B20 Exp. 11/30/2020, G19D77 Exp. 05/31/2020, C19D84 Exp. 05/31/2020, D19A77 Exp. 05/31/2020, D19E40 Exp. 05/31/2020 3 I19C45 Exp. 11/30/2020, E19E42 Exp. 11/30/2020, G19B41 Exp. 11/30/2020, H19C77 Exp. 11/30/2020, E19A34 Exp. 05/31/2020 4 H19B61 Exp. 11/30/2020, H19C82 Exp. 11/30/2020, C19A18 Exp. 05/31/2020, C19B13 Exp. 05/31/2020, D19B77 Exp. 05/31/2020, E19B76 Exp. 05/31/2020 5 I19B41 Exp. 11/30/2020, D19D51 Exp. 05/31/2020, F19C33 Exp. 05/31/2020 - Amount recalled
- N/A
Where it was sold
Why it was recalled
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
This product could cause temporary or reversible health problems — stop using it.
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