Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot#: 28DE2002 Exp 10/31/22
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Direct Rx
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
Product Codes/Lot Numbers:
Lot#: 28DE2002 Exp 10/31/22
Distribution:
Distributed in: GA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0300-2021
Related Recalls
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle