March 2021 FDA Recall Drug by Direct Rx
D-0300-2021 - cGMP deviations
This Class II drug recall was voluntarily initiated by Direct Rx on March 2, 2021 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in GA and the recall is currently terminated.
Recall Number: D-0300-2021
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.
03-02-2021
03-24-2021
17 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Direct Rx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
GA
09-21-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
Batch or Lot Expiration Information
Lot# : 28DE2002 Exp 10/31/22
