Reported Mar 24, 2021 · Terminated
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx…
Direct Rx
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Direct Rx · 94 Worldwide Dr · Dawsonville, GA · 30534-6828
Is this the product you have?
- Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only
- Packaged and Distributed ByDirect Rx Dawsonville, GA, NDC 6191985330
- Lot codes and dates
- Lot#: 28DE2002 Exp 10/31/22
- Amount recalled
- 17 bottles
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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