ATRACURIUM BESILATE 10mg/ml Ampoule for Injection (Tracrium (10mg/ml))

Brief description of the problem (reason for recall)

This recall is initiated because of the potential serious risk following detected glass particles in some samples of the above-mentioned ampoule batches.

Advice for health professionals and distributors:

Aspen SA Sterile Operations urges you to quarantine and return the batches mentioned above without delay. Wholesalers, Distributors, hospitals, authorised clinics, and pharmacies that have the affected batches should stop distributing them, and health practitioners should stop using these affected batches immediately.

Adverse reactions or quality problems experienced with the use of this product may be reported through contacting Aspen Pharmacare’s Medical Information Line on 0800 118 088 or SAHPRA.

Proposed action taken and its urgency: A SAHPRA-approved recall letter was distributed to all distribution points, and the recall process was initiated. A rapid alert was also shared with PIC’s member countries.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.