Drug product
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
D-0300-2021
Product summary
- Firm
- Direct Rx
- Event
- Event 87458
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 bottles
- Official record key
drug-enforcement:D-0300-2021
Official wording
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.
Code information: Lot#: 28DE2002 Exp 10/31/22
Distribution pattern: GA
Derived failure modes
-
Manufacturing or process control
cGMP deviations