Lerumo Immunity

Brief description of the problem (reason for recall)

This recall was initiated due to an isolated manufacturing process deviation and raw material non-compliance identified during an internal retrospective audit.

Advice for health professionals and distributors:

To maintain absolute compliance and ensure a swift, successful recall audit trail, Bio Services CC kindly request

that you take the following actions immediately:

1. Inventory Audit: Immediately check your physical stock, dispensary shelves, and all storage

areas to identify if you hold any units of the affected batch(es) listed above.

2. Cease Distribution & Dispensing: Stop selling, distributing, or dispensing the affected

batch(es) immediately.

3. Quarantine Stock: Safely segregate and quarantine all remaining affected units in a secure

area to prevent accidental handling or dispensing.

4. Complete the Response Form: Complete the attached Customer Acknowledgement &

Stock Reconciliation Form and email it back to mark@bioservices.co.za within 7 – 14

working days. Note: This form must be completed and returned even if you currently

have zero stock of the affected batches.

5. Physical Return of Stock: Arrange for the physical return of the quarantined stock through

your standard reverse logistics channel.

Contact Person: Mark Finnegan

• Office Hours Telephone: 0798950397
• After Hours / Emergency Telephone: 0798950397
• Email Address: mark@bioservices.co.za

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

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.