The Department of Health (DH) today (March 22) endorsed a licensed pharmaceutical manufacturer, Medipharma Ltd, to recall all batches of Cinotec Cream 0.005% (registration no. HK-40871) and 0.0125% (HK-40873) from the market due to a quality issue.
Following the recall of five batches of the above two pharmaceutical products reported on August 3, 2016, more samples were obtained for analysis. Test results from the Government Laboratory revealed that the content of the active ingredient of some batches of the two products was lower than claimed on the label.
As a precautionary measure, Medipharma has suspended the manufacturing of the two products since the last recall. In view of the latest test results, it is recalling all batches of the two products from the market. Investigations revealed that an inadequate mixing in the manufacturing process might have led to non-uniformity of the content of the active ingredient.
Cinotec Cream, containing fluocinolone acetonide, is a steroid cream and a prescription medicine for the treatment of eczema and allergic skin disorders. According to Medipharma, the two products have been supplied to the Hospital Authority, DH clinics, private doctors and pharmacies.
"The products under recall might have reduced efficacy in relieving symptoms but should pose no harmful effects to patients," a spokesman for the DH said.
Medipharma has set up a hotline (2408 9171) to answer related enquiries.
"We will closely monitor the recall. No adverse reports in connection with the two products have been received so far," the spokesman said.
Members of the public using the two products should consult their healthcare providers if in doubt or when symptoms persist.
Reprinted from HKSAR Government:
http://www.info.gov.hk/gia/general/201703/22/P2017032200503.htm