August 2022 FDA Recall Clomipramine Hydrochloride by Leading Pharma, Llc
D-1546-2022 - Superpotent Drug
This Class III drug recall was voluntarily initiated by Leading Pharma, Llc on August 23, 2022 for the product Clomipramine Hydrochloride. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1546-2022
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
08-23-2022
10-05-2022
960 bottles (100 capsules)
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Leading Pharma, LLC
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.
Nationwide within the United States
09-28-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
Batch or Lot Expiration Information
Lot# : B14221, Exp. Date 02/2023
