Lactulose concentrate API (Lactulose Concentrate solution- 66% and 70% )nsoprazole)

Reason for recall

The product was being recalled due to quality defect:The product was found to have microbial counts with yeast (Millerozyma farinose) and mould; the count was above specification. Out of Specification results were then reported by customer whilst using customer method (undiluted), which was confirmed by the manufacturer using customer method. The recall was requested based on the presence and count of the organism.

Recall process: Recall letters have been distributed to all Distributors.

Advice to HCPs/Distributors/Public:

The manufacturer requested for the immediate return of all the affected batches of Lactulose concentrate API to the supplying distributor without delay. As a precautionary measure, distribution remains on hold for all stock on site at the manufacturer and no manufacturing is taking place until corrective measures are confirmed.

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.