Clomipramine Hydrochloride Capsule
FDA Recall NDC 69315-166
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Clomipramine Hydrochloride (NDC 69315-166). A significant event, classified as Class III, was initiated on Aug 23, 2022 by Leading Pharma, Llc. The reported reason for this action was: "Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Aug 23, 2022
Oct 05, 2022
960 bottles (100 capsules)
Recall Profile & Regulatory Data
Event ID
90853
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Leading Pharma, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 28, 2023
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
Batch or Lot Expiration Information
Lot# : B14221, Exp. Date 02/2023
Affected Packages Involved in this Recall
69315-167-03Product
69315-167-01Product
69315-167-09Product
69315-166-03Product
69315-166-01Product
69315-166-09Product
69315-165-03Product
69315-165-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
