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Over the last two days, EOF have recalled different products, for different reasons, in the best interest of consumers.
The products are:-
1) The recall of Lots of medicinal products MUCOSOLVAN SYR 15MG / 5ML & MUCOSOLVAN SYR 30MG / 5ML has been decided by the National Organisation for Medicines because, while the product is contraindicated in children under 2 years of age, on its outer packaging the dosing schedule for this age group, is indicated.
Specifically, the Lots recalled:
MUCOSOLVAN SYR 15MG / 5ML,
Lot no. 171540 with expiry date 09/2020,
Lot no. 171827 with expiry date 01/2021.
MUCOSOLVAN SYR 30MG / 5ML,
Lot no. 728206 with expiry date 10/2020,
Lot no. 728192 with expiry date 10/2020,
Lot no. 728193 with expiry date 10/2020,
Lot no. 728205 with expiry date 10/2020.
2) ELCODROP Omeprazole 40mg / cap
The recall of Lot no. G10618 of the medicinal product ELCODROP Omeprazole 40mg / cap. with expiry date of 06/2021, because the results of the uniformity-mass control carried out in the sample did not comply with the specifications. DOC PHARMA SA, as the holder of a product marketing authorization in Greece, must contact its customers immediately in order to withdraw it from the market.
3) GILUDOP C/S.SOL.IN 50MG/5ML
The recall of Lot no. 095598 of the medicinal product GILUDOP C / S.SOL.IN 50MG / 5ML with expiry date 10/2020.
This decision is issued under preventive safeguarding of public health, in order to strengthen the voluntary recall made by the Company PHARMASELECT INTERNATIONAL BETEILIGUNGS GMBH, as colouring of the solution was detected in some ampoules of the product during the stability study.
4) KARVOFIL 300mg / tab.
The withdrawal of Lot no. 800452, expiring in January 2021, of KARVOFIL 300mg / tab medicinal product. EOF proceeded in the recall, after detection of the NDEA substance (a possible carcinogen) at levels above the permissible limits.
VOCATE PHARMACEUTICALS SA as the marketing authorization holder of the products in Greece must contact the recipients of the particular batch immediately and withdraw it from the market within a reasonable time.
While Pharmacovigilance Risk Assessment Committee (PRAC) recommends restrictions in use of Xeljanz while PRAC reviews risk of blood clots in lungs. Read more here – https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-13-16-may-2019.
At the same time, EOF proceeded to recall Lots of cosmetics.
Powder Lovie CONTOUR PERFECTION No 221. (Lot no. 03030217), the preservative Ethylparaben was detected, while not listed on the label of the package.
Powder Lovie Compact Powder No.203A. (Lot no. 03040117). The preservative Phenoxyethanol has been detected while not listed on the label of the package. Also, on the label is indicated the Ethylparaben preservative, while it was not detected during laboratory testing.
Powder Lovie Terracotta Multi, Eyeshadow, No18. (Lot no. 4030250). The preservative Isobutylparaben, while not listed on the label of the package.
Powder (Eye Shadow) Lovie Terracotta Multi, No22. (Lot no: 4060041). The preservative Isobutylparaben, while not listed on the label of the package.
Lovie Cream Make up oil free No2 (Lot no. 16470). Heterogeneous mixture with visible two-phase separation.
Powder Lovie Compact Powder No 2015A. (Lot no. 03031117). The preservatives Phenoxyethanol, Methylparaben, Propylparaben, Butylparaben were detected, while not listed on the label of the package.
Lipstick Lovie MATTE lipstick Hyaluronic Acid & Argan Oil, Paraben free No 216. (Lot no. 161 498). The preservative Methylparaben was detected, while not listed on the label of the package.
According to the EOF, the decision is issued in the context of the protection of public health. LOVIE COSMETICS ATHENS, which has made these lots available on the Greek market, must contact the recipients of the products directly in order to withdraw them.
“CADUTA Reinforcement Shampoo for Hair Loss”. EOF proceeded with the recall of Lot no. 2400515 of the cosmetic product “CADUTA Reinforcement Shampoo for Hair Loss” , because the result of the laboratory tests carried out, by the Laboratory Directorate of the EOF, on a sample of the product does not match with the products pH specifications. The company FAIR HAIR I. VALAVANIS & Co. EU, has to contact the recipients of the Lot immediately in order to withdraw it.
