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Product Recalls

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.

  1. Sodium Valproate Enteric Coated Tablets 100mg manufactured by Ambalal Sarabhai Enterprises Ltd, India (with effect from 04.01.2011)
  2. Fluoxetine Capsule 20mg manufactured by RPG Life Sciences Ltd, India (with effect from 11.02.2011)
  3. Promethazine Oral Solution 5mg in 5ml manufactured by Biodeal Laboratories Pvt Ltd, India (with effect from 19.05.2011)
  4. 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.