D-0300-2021 Class II Terminated
FDA drug recall D-0300-2021 was initiated by Direct Rx on March 2, 2021 and is designated Class II. 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 fo… The recall status is terminated (terminated September 21, 2021). Affected quantity: 17 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 24, 2021
- Initiation Date
- March 2, 2021
- Termination Date
- September 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 bottles
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.
Distribution Pattern
GA
Code Information
Lot#: 28DE2002 Exp 10/31/22