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All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holder (MAH) on the affected batches of the subject products from the market. The details of the products are as follows:

1. Specific Batches of Clozapine 25 mg Tablet [Ziproc-25] and Clozapine 100 mg Tablet [Ziproc-100]

GENERIC NAME CLOZAPINE
BRAND NAME Ziproc-25 Ziproc-100
DOSAGE STRENGTH 25 mg Tablet 100 mg Tablet
REGISTRATION NO. DRP-3291 DRP-3289
PACKAGING ALU/PVC Blister Pack of 10’s (Box Of 100’s)
BATCH NO./

EXP. DATE

B345J001

31 January 2024

B344J001

31 December 2023

MANUFACTURER TORRENT PHARMACEUTICALS LTD- Near Indrad Village, Taluka Kadi, District Mehsana, Gujarat, India
IMPORTER & DISTRIBUTOR TORRENT PHARMA PHILIPPINES, INC.

– Units 3 & 4, 34F Zuellig Building, Makati Ave. cor. Paseo de Roxas, Makati City

Clozapine is used in the management of schizophrenia; patients who fail to respond to or experience severe extrapyramidal side effects with classical anti-psychotics; reducing the risk of recurrent suicidal behavior in patients with schizophrenia; and management of treatment-resistant psychoses associated with Parkinson’s disease.

The MAH pursued the voluntary recall of the drug products due to the Out-of-Specification result reported in dissolution test at long-term (30 °C/75% RH) stability condition. The identified out-of-specification may cause underdosing during medication therapy which may pose health risks (e.g., adverse reactions, life-threatening events) to the target patients.  Therefore, the stated batches present quality and safety concerns.

Distributors, hospitals, retailers, pharmacies, or clinics that have the affected batches of the drug products are therefore instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product batches and may contact Torrent Pharma Phils., Inc through [email protected]   for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product batches are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the products should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.

Dissemination of the information to all concerned is requested.

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