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Nintedanib 100 Mg Cipla And Nintedanib 150 Mg Cipla

Official source

Source domain: sahpra.org.za

Collected on 28 July 2026

Always confirm details on the official source before acting.

What this means

This document is a SAHPRA “Product Recall Unit” notice for Nintedanib 100 mg Cipla and Nintedanib 150 mg Cipla. It states that a recall was initiated due to product quality complaints that the soft-gel capsules clump/stick together. Cipla Medpro (Pty) Ltd advises health professionals and distributors to refrain from selling/dispensing affected batches and to return them for full credit/replacement, and notes that a SAHPRA-approved recall letter was distributed to distribution points. The notice is dated 23 Jul 2026 and updated 21/07/2026, with the recall date listed as 21 July 2026 and a Class II (Type B) classification.

Facts

Reference

POSTED 23 JUL 2026

Key Takeaways

  • SAHPRA product recall notice for Nintedanib 100 mg Cipla and Nintedanib 150 mg Cipla
  • Reason: soft-gel capsules clumping/sticking together (product quality complaints)
  • Company: Cipla Medpro (Pty) Ltd, Building 2 Junxion Park, 10 Elephant Lane, Century City, South Africa 7441
  • Registration numbers: 56/26/0704.702 (100 mg) and 56/26/0705.703 (150 mg)
  • Batch numbers: 6KA0781 and 6KA0782; expiry date 01.2028 for both
  • Pack size: 60’s; first release date: 14.04.2026 for both
  • Recall classification: Class II, Type B
  • Recall date: 21 July 2026; notice posted 23 Jul 2026 at 11:33h
  • Action: do not sell/dispense affected packs; return to supplying warehouse/distributor for full credit/replacement
  • Customer care line: 080 222 6662
  • South African Health Products Regulatory Authority (SAHPRA)
  • Cipla Medpro (Pty) Ltd
  • Ntokozo Msiza

Dates

Closing Date

14 April 2026