Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
Reported: March 24, 2021 Initiated: March 2, 2021 #D-0300-2021
Product Description
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.
Details
- Recalling Firm
- Direct Rx
- Units Affected
- 17 bottles
- Distribution
- GA
- Location
- Dawsonville, GA
Frequently Asked Questions
What product was recalled? ▼
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330. Recalled by Direct Rx. Units affected: 17 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 24, 2021. Severity: Moderate. Recall number: D-0300-2021.
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