BY MA. CRISTINA C. ARAYATA
Abbot Laboratories (Philippines) immediately initiated the voluntary recall of Trifusal 300mg capsule (Grendis) Batch Number 8003 up to retail level, after receiving complaints from the Malaysian market that another batch of the product (H005) distributed in Malaysia had a “bad smell”.
Trifusal is an anti-platelet drug which can only be bought with a doctor’s prescription.
The details provided are as follows: Registration Number DR-XY30166; Manufactured March 2013; Expiration March 2016; J. Uriach & CIA, S.A. AV. Cami Reial 51-57, 08184 Palau Solita I Plegamans, Barcelona, Spain (Manufacturer’s name and address).
Investigation concluded that the smell was due to an increase of HTB, 4-trifluoromethylsalicylic acid (aka 2-Hydroxy-4-triflouromethyl) Benzoic acid. It added that the increase in impurity is due to a damage of the refrigeration system of the equipment used in Active Pharmaceutical Ingredient (API) manufacturing process.
Even if the H003 distributed in the Philippines was manufactured using a different lot number of API from that of the H005, the manufacturing site confirmed that batch H003 was impacted by the same damage of refrigerator system.
The Philippine Food and Drug Administration (FDA) and the Department of Health said all pharmacies should locate and remove the affected batch from their facility. Also, consumers are advised to return the affected product to where it was purchased. With an FDA report
VitalSigns Issue 62 Vol. 3, April 1-30, 2014