Shal’Artem (Artemether 180mg and Lumefantrine 1080mg for oral suspension
Summary
Date Recall was issued:
Product Name:
Manufacturer:
Recalling Firm:
Batch(es):
Manufacturing Date:
Expiry Date:
Reason for Recall:
9th January 2025Â
Shal’Artem (Artemether 180mg and Lumefantrine 1080mg for oral suspensionÂ
Shalina Laboratories Pvt Limited, IndiaÂ
Shalina Healthcare Gh Ltd
3390218, 3390154Â
July 2023, June 2023 Â
June 2026, May 2026  Â
Substandard product, failed assay for Artemether as per the acceptance criteria in the International Pharmacopoeia.
Announcement
This recall is necessitated as a result of warehouse market surveillance conducted at the warehouse. Actual product specification is a powder for oral suspension. The affected batches were caked and not free flowing. This makes the product substandard and therefore not recommended for its intended use.
