Recall Enforment Report D-1546-2022

Drug Recall Enforcement Report Class III voluntary initiated by Leading Pharma, LLC, originally initiated on 08-23-2022 for 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 The product was recalled due to superpotent drug: assay value found to be 110.6% in chlomipramine hydrocholoride capsules. The product was distributed nationwide and the recall is currently terminated.

Field Name Field Value
Event ID 90853 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-1546-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
Reason For Recall Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 960 bottles (100 capsules) Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 10-05-2022
Recall Initiation Date 08-23-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Termination Date 09-28-2023 What is the Date Terminated?
The date that FDA terminated the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Leading Pharma, LLC
Code Info Lot#: B14221, Exp. Date 02/2023 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 69315-167-03; 69315-167-01; 69315-167-09; 69315-166-03; 69315-166-01; 69315-166-09; 69315-165-03; 69315-165-01
Status Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
69315-165Clomipramine Hydrochloride Clomipramine HydrochlorideCapsuleOralLeading Pharma, LlcHuman Prescription Drug
69315-166Clomipramine Hydrochloride Clomipramine HydrochlorideCapsuleOralLeading Pharma, LlcHuman Prescription Drug
69315-167Clomipramine Hydrochloride Clomipramine HydrochlorideCapsuleOralLeading Pharma, LlcHuman Prescription Drug