Recalls / Class II
Class IID-0300-2021
Product
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
- Affected lot / code info
- Lot#: 28DE2002 Exp 10/31/22
Why it was recalled
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.
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, N/A, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 17 bottles
- Distribution pattern
- GA
Timeline
- Recall initiated
- 2021-03-02
- FDA classified
- 2021-03-12
- Posted by FDA
- 2021-03-24
- Terminated
- 2021-09-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0300-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.