Levoneptin 100 and Levoneptin 400 (Gabapentin)

Brief description of the problem (reason for recall)

This recall was initiated as Ascend Laboratories (Pty) Ltd identified that the batches listed above may not comply with the approved finished product stability specifications. The issue was detected during routine evaluation and testing of retained control samples, where an out-of-specification (OOS) result was observed for individual impurity. The impurity level exceeded the established acceptance criteria, indicating a potential deterioration in product quality over its shelf life. As a result, there is a risk that the affected batches may not consistently meet the required stability standards throughout the approved storage period, prompting the precautionary recall of the impacted batches from the market.

Advice for health professionals and distributors:

We kindly request that you immediately identify, isolate, and remove all affected units of the specified batches from your inventory. The affected stock should be returned to DP World Healthcare Logistics as the established distribution channel to facilitate the recall process. Please ensure that no remaining units of the affected batches are supplied, distributed, or dispensed. Should you require any further information or have any queries regarding this recall, please contact our Customer Care Line on 010 276 0037.

We apologise for any inconvenience you may have experienced and appreciate your cooperation in this regard.

Proposed action taken and its urgency: A SAHPRA-approved recall letter was distributed to all distribution points and the recall process was initiated.