During the year 2011, the market authorization of following products of pharmaceuticals and medical devices were cancelled for a period of one year from the respective dates of cancellation due to continuous quality failures.
- Sodium Valproate Enteric Coated Tablets 100mg manufactured by Ambalal Sarabhai Enterprises Ltd, India (with effect from 04.01.2011)
- Fluoxetine Capsule 20mg manufactured by RPG Life Sciences Ltd, India (with effect from 11.02.2011)
- Promethazine Oral Solution 5mg in 5ml manufactured by Biodeal Laboratories Pvt Ltd, India (with effect from 19.05.2011)
- Disposable Syringe with Needle, 10ml manufactured by Anhui Tinkang Medical Products Co. Ltd, China (with effect from 05.07.2011)
After a period of one year, new applications shall be submitted in order to reconsider market authorization for above recalled products.