Ministry of Health and Prevention recalls pharmaceutical products and medical devices

UAE, June 20, 2017 - H.E. Dr. Amin Hussein Al Amiri, Assistant Undersecretary for Public Health Policy and Licensing of the Ministry of Health & Prevention and Chairman for Supreme Pharmacovigilance committee, announced that the Ministry of Health and Prevention has recently issued four administrative circulars to withdraw some batches of a pharmaceutical product and medical devices from the local market. The move was in pursuant of Federal Law No. (4) of 1983 concerning pharmaceuticals and related companies and Ministerial Resolution No. (366) of 2010 governing withdrawal, suspension, or prevention of circulation of pharmaceutical and medical products.

According to H.E. Dr. Al Amiri, the Ministry partners with local health authorities to guarantee drug safety across the UAE, as part of a comprehensive medicine security to prevent public health issues through maximum health precautions. 

Individuals suffering from any drug related side effect may report the same by filling out a form available at http://www.cpdpharma.ae. They may also dial 04-2301448, fax: 04-2301947, or e-mail: pv@moh.gov.ae. 

One of the circulars ordered the recall of some batches of Human Albumin Biotest 5% & 20% solutions. The manufacturer voluntarily recalled the products, citing production defect and contamination with ethylene glycol used for cooling in the manufacturing process. This medicine is albumin extracted from human plasma and used for stabilizing the circulating blood volume. The product is registered by the Ministry’s Drug department, as such, the Ministry directed the local distributor to withdraw the products from the local market and warned all healthcare practitioners to not use these batches if available at their facilities. 

Similarly, the second circular was issued concerning safety and recall of Fluconazole injection, in Intravia Plastic Container, 200mg/100ml manufactured by Baxter Healthcare Corporation, and indicated for the treatment and prevention of fungal infections when its efficacy has been established through culture. The manufacturer voluntarily pulled out the product due to product packaging leakage.

The recalled product carries the following data:
Operation number    Expiry date
P348136    30/04/2018
P352377    31/08/2018
The product is not registered with the Ministry’s Drug Department. However, the Ministry decided to issue the circular to ensure patient safety. 

The third circular called for the withdrawal of one batch of the vacutainer plus serum separator tube produced by Becton Dickinson. The company voluntarily recalled one batch of the specified medical device, with number 6166824 and expiry date on December 31, 2017. The blood collection tube was recalled due to the presence of small particles in the operating tube. 

The product is not registered with the Ministry’s Drug Department. However, the Ministry decided to issue the circular to ensure patient safety. 
 
Lastly, the fourth circular directed the recall of BD Precision Glide Needle 18G x 1 RB by Becton Dickinson. The manufacturer voluntarily withdrew the defective product used as a needle for subcutaneous injection and with batch number 5299561because the needle could break and leak medicine when inserted under the skin. The product is not registered with the Drug Department but the circular formed part of the Ministry’s preventive measures to protect patients in the UAE.