Drug recall
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC…
FDA recall event 84422 · Class II · Preferred Pharmaceuticals, Inc
Key facts
| Event ID | 84422 |
|---|---|
| Recall numbers | D-0617-2020 |
| Recalling firm | Preferred Pharmaceuticals, Inc |
| Product type | Drugs |
| Products | Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: Presence of NDMA impurity detected in product. |
| Initiation date | Dec 2, 2019 |
| Report date | Dec 18, 2019 |
| Termination date | May 9, 2023 |
| City | Anaheim |
| State | CA |
| Country | United States |
| FEI number | 3004582966 |
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: