Drug Enforcement D-1546-2022

Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

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Status

Terminated

Classification

Class III

Report Date

October 5, 2022

Termination Date

September 28, 2023

Product Information

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
Product quantity
960 bottles (100 capsules)
Reason for recall
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Leading Pharma, LLC
Address
3 Oak Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1546-2022
Event ID
90853
Recall initiation date
August 23, 2022
Center classification date
September 28, 2022
Code info
Lot#: B14221, Exp. Date 02/2023
More code info
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