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The Food and Drug Administration (FDA) notifies the public on the WHO Medical Product Alert on five (5) substandard (contaminated) pediatric drug products manufactured (as stated in label) by Pharmix Laboratories (Pvt.) Ltd. that have been identified in the Americas, Eastern Mediterranean, Southeast Asia, and Western Pacific Regions in November 2023:

  1. Alergo Syrup
Batch No. Manufacturing date Expiry date Identified in
L126 27/12/2021 26/12/2023 Pakistan
B220 16/02/2022 15/02/2024 Belize, Fiji, Lao PDR, Maldives, Pakistan
G204 05/07/2022 04/08/2024 Maldives
L210 12/12/2022 11/12/2024 Maldives
K222 16/11/2022 15/11/2024 Maldives
J242 26/10/2022 25/10/2024 Maldives
  1. Emidone Suspension
Batch No. Manufacturing date Expiry date Identified in
B227 25/02/2022 24/02/2024 Pakistan
  1. Mucorid Syrup
Batch No. Manufacturing date Expiry date Identified in
A210 10/01/2022 09/01/2024 Pakistan
A211 19/01/2022 18/01/2024 Pakistan
A212 19/01/2022 18/01/2024 Pakistan
A230 29/01/2022 28/01/2024 Pakistan
B201 03/02/2022 02/02/2024 Pakistan
B224 18/02/2022 17/02/2024 Pakistan
B225 21/02/2022 20/02/2024 Pakistan
C210 08/03/2022 07/03/2024 Pakistan
C227 21/03/2022 20/02/2024 Pakistan
L111 13/12/2021 12/12/2023 Pakistan
L121 20/12/2021 19/12/2023 Pakistan
  1. Ulcofin Suspension
Batch No. Manufacturing date Expiry date Identified in
B209 08/02/2022 07/02/2024 Pakistan
C223 17/03/2022 16/03/2024 Pakistan
  1. Zincell Syrup
Batch No. Manufacturing date Expiry date Identified in
C218 11/03/2022 10/03/2024 Pakistan

The FDA strongly advises the public to be vigilant on the circulation of these substandard drug products since its contaminants, Diethylene Glycol and Ethylene Glycol, are toxic to humans when consumed above the acceptable limit and may result to abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death. Substandard drug products are products that fail to meet either their quality standards or specifications. To date, there is no reported adverse effects linked to the affected products have been notified to WHO. Furthermore, the Drug Regulatory Authority of Pakistan (DRAP) instructed the manufacturer to stop their production of oral liquid dosage forms, and issued a Recall Alert for these products, as precautionary measures.

This is to emphasize that the abovementioned drug products are not registered with FDA. However, it is important to detect and remove these products from circulation to prevent harm to patients.

Therefore, all Local Government Units (LGU) and Law Enforcement Agencies (LEAs), after the issuance of this advisory, are requested to ensure that these substandard drug products are not sold or not administered to patients in their localities or areas of jurisdiction. Furthermore, manufacturers of liquid dosage forms, especially syrups that contain excipients such as propylene glycol, polyethylene glycol, sorbitol, and/or glycerin/glycerol, are urged to test for the presence of the stated contaminants before use in production of pharmaceutical products.

For more information and inquiries, please e-mail us at cdrr_postmarketsurveillance@fda.gov.ph. To report unauthorized sale, or distribution of the abovementioned, kindly e-mail us via cdrr.od@fda.gov.ph. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596.

Dissemination of the information to all concerned is highly requested.

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