Frutenzima Capsulas | Capsula Toys | De Gelatina

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DIGEMID ALERT No. 76-2007
PHARMACEUTICAL PRODUCT COUNTERFEIT
FRUTENZIMA CAPSULE

The General Directorate of Medicines, Supplies and Drugs (DIGEMID) of the Ministry of Health, informed health professionals, institutions, pharmaceutical establishments responsible for the supply of drugs in public and private sectors and the general public the following:

1. As a result of control activities and surveillance of pharmaceuticals and related products nationwide, has identified counterfeit batch of pharmaceutical product 00462625 FRUTENZIMA capsule.

2. The manufacturer and owner of Health Registry of the original medicinal capsule FRUTENZIMA Farmindustria Laboratory SA

3. The counterfeit product was seized in the Imperial Multi SRL Pharmaceuticals I located at Av Culture No. 1706 - District Wanchaq-Cusco, sent by the Regional Health Bureau Cusco.

4. 00462625 The batch analysis conducted by the National Center for Quality Control, National Institute of Health, determined that the product does not contain AMYLASE analyzed, metoclopramide hydrochloride and DIMETHICONE, active substances authorized for this medicinal product.

5. The assessment by the DIGEMID in coordination with the owner of Health Registry, has been determined that the said lot do not conform to the specifications authorized in the Health Register.

6. Based on the Ministerial Resolution No. 548-99-SA/DM, the competent Health Authority imposes a fine of 100 ITU to distribute, dispense, store or sell counterfeit pharmaceuticals and proceeds to process the appropriate criminal charges.

7. The distinguishing characteristics of the original and counterfeit product are:

ORIGINAL

Physical characteristic

Hard gelatin capsule, light blue and pink granules containing cream.

Immediate labeled container (blister):

- The printing of the text is crisp and even.
- Printing the lot number and date of maturity is in low relief, uniform and clear.

COUNTERFEIT

Physical characteristic

Hard gelatin capsule, light blue and pink containing a white granular.

Immediate labeled container (blister):

- The printing of the text is overloaded with ink.
- Printing the lot number and date of maturity is the surface relief, is asymmetric and is not sharp.

Due to the risk that the public is exposed to the marketing of counterfeit product is recommended to check before purchasing the lot number of the drug. Also, refrain from acquiring outilizar pharmaceuticals in the suspected contamination, tampering, counterfeiting, forgery or are sold without sanitary registration. Any irregularity relating to pharmaceutical products must be reported to the General Directorate of Medicines, Supplies and Drugs to cell No. 4413047 and No. 4229200 Annex 210.

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