# FDA recall D-0300-2021

> **Direct Rx** · Class II · drug recall initiated 2021-03-02.

## 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.

## Distribution

GA

## Key facts

- **Recall number:** D-0300-2021
- **Recalling firm:** Direct Rx
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-03-02
- **Report date:** 2021-03-24
- **Termination date:** 2021-09-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dawsonville, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0300-2021

## Citation

> AI Analytics. FDA recall D-0300-2021. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-0300-2021. Source: US FDA. Licensed CC0.

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