FDA Advisory No. 2014-026 VOLUNTARY PRODUCT RECALL OF BATCH - TopicsExpress

FDA Advisory No. 2014-026 VOLUNTARY PRODUCT RECALL OF BATCH SPECIFIC TRIFUSAL 300mg Capsule (GRENDIS) This is to inform the public that Abbott Laboratories (Philippines) has initiated a voluntary recall of Trifusal 300mg Capsule (Grendis) up to retail level. The details of the product are as follows: REGISTRATION NUMBER DR-XY30166 BATCH NUMBER H003 DATE OF MANUFACTURE MARCH 2013 EXPIRY DATE MARCH 2016 MANUFACTURER NAME AND ADDRESS J. URIACH & CIA, S.A AV. CAMI REIAL 51-57, 08184 PALAU SOLITA I PLEGAMANS, BARCELONA, SPAIN Abbott received a complaint from Malaysian Market that another batch of the product (H005) which has been distributed to Malaysia had a Bad Smell. The result of the investigation of the manufacturing site concluded that the bad smell was due to an increase of one known impurity name HTB, 4-trifluoromethylsalicylic acid (Also known as 2-Hydroxy-4-(triflouromethyl) Benzoic acid. The increase in the impurity is related to a damage of the refrigeration system of the equipment used in the manufacturing process of the active Pharmaceutical Ingredient (API). The batch number H003 distributed in the Philippines was manufactured using a different lot number of API (Trifusal) that is from that of the complaint batch (H005). However, the API manufacturing site confirmed that batch H003 was impacted by the same event (damage of refrigerator system) All pharmacies should be locate and remove the affected batch from their facility. Consumer are advised not to use the affected of the product and return it to where it was purchased. Trifusal is an antiplatelet drug indicated for secondary prevention after a first coronary or cerebrovascular ischemic event of myocardial infarction, stable and unstable angina, non-hemorrhagic stroke or transient ischemic atatck, and reduction of vein graft occlusion after bypass surgery For more information and inquiries, please e-mail us at [email protected]. Any adverse reaction caused by the aforementioned product should be immediately reported to FDA at [email protected]

Mvuvi mmoja anahofiwa kufariki huku wengine wawili wakinusurika

“You spirit operating in the life of my loved one, blinding our

Cyber Monday Sale Madison Park Genevieve 7 Piece Comforter Set

Semoga perdamaian ini menjadi sebuah wujud introspeksi diri, dan

Watch and Act Issued For: Lancefield Fire Origin:

Acesse agora mesmo a página da dupla

Queridos amigos animalista a quienes sus mascotas fueron