Republic of the Philippines - Department of Health Fi FOOD AND DRUG ADMINISTRATION — LEAS FDA Advisory 03 NOV 2015 No. __2015 -080 SUBJECT: PRODUCT RECALL OF BATCH SPECIFIC ATORVASTATIN (as CALCIUM) 40mg FILM-COATED TABLET (ORVAKLINE) ‘The public is hereby warned by the Food and Drug Administration (FDA) that the following batch of Atorvastatin (as Calcium) (Orvakline) 40 mg Film-coated Tablet is being recalled from the market.The details of the product are as follows: REGISTRATION NUMBER DR-XY40918 BATCH NUMBER /EXPIRY 403843 / APRIL 2016 DATE MANUFACT! DR. REDDY’S LABORATORIES. AND ADDRESS. LIMITED ~ SURVEY NO. 41, BACHUPALLY VILLAGE, QUTUBULLAPUR MANDAL, RANGA. REDDY DISTRICT, ANDHRA PRADESH, INDIA as IMPORTER/DISTRIBUTOR GLAXOSMITHKLINE PHILIPPINES, INC 2266 DON CHINO ROCES AVE., | MAKATI CITY ‘The importer reported that an Out-of-Specification (OOS) in assay was obtained on the ninth (9) month testing point during the stability studies (30°C/75% RH) on the ‘mentioned batch of the drug product. Thus, there is no guarantee of good quality and safety at the ninth (9") month shelf-life of the subject drug product and beyond, Atorvastatin (as Calcium) (Orvakline) 40 mg Film-coated Tablet is used for the treatment of hyperlipidaemias, including hypercholesterolaemias and combined hyperlipidaemia (type Ha or IIb hyperlipoproteinaemias), hypertriglyceridaemia (type IV). The product is packed in blister pack by 7 tablets/box of 28’s and blister pack by 10 tablets/box of 30s. The affected product batch presents safety risks and potential adverse health consequences. Therefore, distributors, retailers, hospitals, pharmacies or clinics that have the affected batch of Atorvastatin (as Calcium) (Orvakline) 40 mg Film-coated Tablet are instructed to discontinue further distribution, sale and use. All consumers are likewise advised not to purchase or use the affected product batch. Please contact GlaxoSmithKline Philippines, Inc. at telephone numbers 892 0761 or e-mail us at info@fda, gov ph for any questions or additional information regarding the recall. Trunk Line $632 887 1900, Fax +692 9970751 Website: www. f8g00.ph malt Info@fda.govph Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines Al|=All field Food Drug Regulation Officers are ordered to monitor the availability of the product batch in the market, to seal the discovered stocks of the affected batch of the product, and to instruct the concerned establishment to give back the sealed stocks to the Marketing Authorization Holder (MAH) for proper destruction to be witnessed by an appropriate FDA Representative. Any suspected adverse reaction experienced from the use of the aforementioned product batch should be reported immediately to FDA by visiting www. fila. gov ph/adr-report-new and fill-out all of the required fields. uw )RETO-GARIN, MD, MBA-H Secretary of Health Acting Director General! JANETTE P. DTN: 2015091415253 "Pursuant to DPO 2015-1843 2of2