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Class II: temporary or reversible health riskTerminated

Direct Rx Nortriptyline HCL capsules Recall

Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and…

Direct Rx · Dawsonville, GA

Risk level
Class II
Reported by FDA
Mar 24, 2021
Recall ID
D-0300-2021
Check your lot numberHow we source this data

Summary

Direct Rx recalled Nortriptyline HCL capsules starting Mar 2, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0300-2021 on Mar 24, 2021. Reason: 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. Status: Terminated.

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.

Product description

Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330

Lot numbers, UPCs & expiration codes

Lot#: 28DE2002 Exp 10/31/22

Where it was sold

GA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0300-2021
Classification
Class II
Status
Terminated
Recall initiated
Mar 2, 2021
FDA report date
Mar 24, 2021
Quantity
17 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Direct Rx

Original FDA data

Every field from FDA enforcement report D-0300-2021, exactly as published.

Show all FDA fields
City
Dawsonville
State
GA
Status
Terminated
Country
United States
Event ID
87458
Address
94 Worldwide Dr
Code information
Lot#: 28DE2002 Exp 10/31/22
Postal code
30534-6828
Report date
Mar 24, 2021
Product type
Drugs
Recall number
D-0300-2021
Classification
Class II
Recalling firm
Direct Rx
Product quantity
17 bottles
Termination date
Sep 21, 2021
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
Distribution pattern
GA
Recall initiation date
Mar 2, 2021
Initial firm notification
Letter
Center classification date
Mar 12, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0300-2021, published Mar 24, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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