Drug recall
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct…
FDA recall event 87458 · Class II · Direct Rx
Key facts
| Event ID | 87458 |
|---|---|
| Recall numbers | D-0300-2021 |
| Recalling firm | Direct Rx |
| Product type | Drugs |
| Products | Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified… |
| Initiation date | Mar 2, 2021 |
| Report date | Mar 24, 2021 |
| Termination date | Sep 21, 2021 |
| City | Dawsonville |
| State | GA |
| Country | United States |
| FEI number | 3011690045 |
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: