By: Cindy Carreto
Carbohydrates, Lipids, Dairy protein – The Department of Regulation and Control of Pharmaceutical and Related Products, of the Guatemalan Health Ministry has issued the Jef.DRCPFA-01-2024 statement regarding the Alert Related to Counterfeiting of the Ledestil product (Carbohydrates, lipids totals, milk protein).
- The statement purpose it´s to inform that the Regulation and Control of Pharmaceutical and Related Products Department, through the National Pharmacovigilance Program, indicates that the alert was received through a complaint made by the LABORATORIOS VIZCAÍNO SA company, which announces the counterfeit, marketed through pharmacies and drugstores such as:
- The product in question has a current Health Registry in Guatemala, so professional health personnel and the general population are requested to take the necessary precautions to avoid acquiring or using counterfeit medicines, considering them to be of high risk to health.
The medicines with current Health Registration in Guatemala are as follows:
- LEDESTIL (Carbohydrates, total lipids, milk protein) Injectable Suspension PF-25029-20253.
- They also tell us how to identify the counterfeit product with the original product, the differences being the following:
Image description: In the counterfeit product, the box has a different printing color than the original product.
Image description: The counterfeit product has typography that differs from the original product. It also indicates an incorrect expiration date, which is not recognized by the manufacturing company.
Image description: In the original product, the liquid is white, the ampoule has a white ribbon and the printing of the descriptive texts is blue and does not fade.
In the counterfeit product, the liquid is yellowish in color and a fine white powder is deposited at the bottom. Likewise, not all the ampoules are coded and the batch number printed on the ampoule does not correspond to the batch number on the box.
Image description: The counterfeit product has a sticker with a number that differs from the label of the original product, above the original barcode
Image description: The counterfeit product presents a tray of blisters with a different signature and dimensions, since one of the sides has a discontinuous edge, since the original product, the tray of blisters has round and continuous edges.
Likewise, the syringes and alcohol towels of the counterfeit product are of a different brand than the original product.
Image description: The counterfeit product has a single-sided insert, no version number or footer, unlike the original product.
Image description: The counterfeit product does not have the ® from the Ledestil brand, unlike the original
In view of the above, the Ministry of Public Health and Social Assistance of Guatemala issued the following recommendations:
General population
- Do not use the medicine LEDESTIL (Carbohydrates, total lipids, milk protein) with batch number 21h and with expiration date 12 / 2026; and with lot number 21F129 and with expiration date 06 / 2025, considering that they are not recognized by the owner company, so their safety or effectiveness is not guaranteed.
- If you detect the marketing of the aforementioned counterfeit product, you may report it by email, which must include, as far as possible, the following information: Name of the Establishment or website, Exact address and Evidence of the product. Send your complaint to the email: monitoringdrcpfa@mspas.gob.gt
- If you have used this product and have suffered an adverse reaction/event, it is recommended to go to the doctor immediately and then notify the National Pharmacovigilance Program of the Department of Regulation and Control of Pharmaceutical and Related Products, for the corresponding follow-up, through the following link: www.notificacentroamerica.net or through email:
pharmacovigilancedrcpfa@mspas.gob.gt
Distributors and pharmacies
- Acquire medications from suppliers authorized and validated by the company that owns the health registry, which must have a health license and operating notice, and also have documentation of the legal acquisition of the product.
- If you detect the marketing of the aforementioned counterfeit product, you may report it by email, which must include, as far as possible, the following information: Name of the Establishment or website, Exact address and Evidence of the product. Send your complaint to: monitoringdrcpfa@mspas.gob.gt