Drug recall
ranitidine hydrochloride, USP,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles…
FDA recall event 84820 · Class II · PD-Rx Pharmaceuticals, Inc.
Key facts
| Event ID | 84820 |
|---|---|
| Recall numbers | D-0826-2020 |
| Recalling firm | PD-Rx Pharmaceuticals, Inc. |
| Product type | Drugs |
| 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels. |
| Initiation date | Jan 10, 2020 |
| Report date | Feb 12, 2020 |
| Termination date | Mar 23, 2021 |
| City | Oklahoma City |
| State | OK |
| Country | United States |
| FEI number | 1641825 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: