24 February 2019

Safety Alerts and Warnings of withdrawal pharmaceutical product for month of Jan 2019

Reference: CIR-2019-00000064

To all health facilities / all health care practitioners in Dubai's private health sector:

Dear colleagues ...

 

With reference to the above subject, DHA recommends all health facilities on the warnings and safety were issued by MOHAP for the month of January 2019as following:
 

1.      Withdrawal of Flukit Syrup product used for the treatment of symptoms associated with colds, flu or nasal allergy containing active substances (Cholpheniramine Maleat, Acetaminophhen, Pesudophedrine HCL) due to non-compliance with the MOHAP guidelines, it was not mentioned in the internal leaflet and the outer label of the product mentioned above that "don’t dispense the product for children under 6 years” although it was mentioned to dispense the children doses from 6 month to 6 years. The following is the op characteristics of the two batches as follows:

اسم المنتج /Product Name	التشغيلة المتأثرة / Affected Batch		تاريخ انتهاء الصلاحية / Exp. Date
Flukit Syrup	0011	05 / 2019
	0012	07 / 2019

 

2.      Removal of suspension of registration and withdrawal of seven pharmaceutical products from the production of Oman Pharmaceutical Trading LLC The following is a list of these approved medication for registration.

no	Trade Name الاسم التجاري /	Generic Name الاسم العلمي/
1	Allopurinol	Loric 300mg Tablets
2	Cefuroxiume Axetil	Cefovex 250 mg Tablets
3	Cefuroxiume Axetil	Cefovex 300 mg Tablets
4	Cefixime	Cefim 100 Powder for Oral Suspension
5	levofloxacin	Advaquin 500mg film coated Tablets
6	Omeprazole	Omezyn 20mg capsules
7	clarithromycin	Clariva 500mg Tablets

 

3.      Withdrawal three of Valsartan batchs from the company's Chinese company Zhejiang Huahai Pharmaceuticals, which are used in the treatment of high blood pressure due to the contamination of the active substance Valsartan with N-nitrosodieithylamine (NDEA) carcinogens.

 

Product Nameاسم المنتج /	Affected batchالتشغيلة المتأثرة /
Valsartan Arrow Lab 160 mg	VJSC17004-F
Valsartan Arrow Lab 80 mg	VJSB18007-A
Valsartan Arrow Lab 160 mg	VJSC18010-C

 

4.      Safety alerts from using Nutritional Supplement Quizz Capsules which is used as a natural product for the treatment of diabetes after it has been proven that it  cause lead poisoning

 

5.       Withdrawal of all batch’s of the Losanet 50mg tablet, Losanet 100mg tablet, produced by Pharmaline - Lebanon According to the following specifications:

 

Batch number / رقم التشغيلة	Generic Nameالاسم العلمي /	Trade Name الاسم التجاري/
جميع التشغيلات المسوقة حتى تاريخ 14/01/2019	Losartan Potassium	Losanet 50mg tablet
		Losanet 100mg tablet

 

6.      Safety alerts from using Nutritional Supplement Rhino 5K Capsules for the manufacturer Happy Together, Inc. Which is used as a dietary supplement because it contains two drugs, undeclared, namely: Sildenafil & Tadalafil, knowing that they may cause a sharp drop in blood pressure may reach a dangerous level and can be a significant risk to patients with heart disease and diabetes or high in fat, Who take nitrate-containing drugs

 

1.  To report Adverse Drug Reaction ( ADR ) kindly go through the ( ADR ) electronic link reporting available at the website :  pv@moh.gov.ae
2.  Drug Control Section through the following email address: DrugControl@dha.gov.ae