Nortriptyline HCL capsules — Class II drug recall D-0300-2021
Terminated recall by Direct Rx, reported 2021-03-24, distributed in GA. cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an in
| Recall number | D-0300-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Direct Rx, Dawsonville, GA, United States |
| Recall initiated | 2021-03-02 |
| Classified | 2021-03-12 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2021-09-21 |
| Distributed | GA |
| Quantity | 17 bottles |
| Reason classes | cgmp |
| Lot numbers | 28DE2002 |
| Expiration dates | 2022-10-31 |
Product
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
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 for use by the manufacturing site.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0300-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.