Drug recall
Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz…
FDA recall event 81638 · Class III · RemedyRepack Inc.
Key facts
| Event ID | 81638 |
|---|---|
| Recall numbers | D-0284-2019 |
| Recalling firm | RemedyRepack Inc. |
| Product type | Drugs |
| Products | Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repackaged by: RemedyRepack, Indiana, PA, Original NDC… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine). |
| Initiation date | Nov 7, 2018 |
| Report date | Dec 5, 2018 |
| Termination date | Apr 1, 2019 |
| City | Indiana |
| State | PA |
| Country | United States |
| FEI number | 3005841768 |
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: