Ciprofloxacin 250 MG Austell (Ciprofloxacin Hydrochloride)

Brief description of the problem (reason for recall)

This recall is initiated due to:

• The inclusion of an outdated Patient Information Leaflet (PIL).
• The package insert did not meet the requirements of Regulation 11.
• No Patient information leaflet was available in the sampled pack.
• The label of the product was reviewed, and it was noted that it is not compliant with Regulation 10(1)(h)(i), Regulation 10(1)(q), and the address of the HCR.

Advice for health professionals and distributors:

As a precautionary regulatory measure, we request that:

• Distribution and sale of the affected batches cease immediately.
• All units on hand be returned to your supplying wholesaler or distributor for full credit.

Please retain this communication in a prominent position for one month to account for any stock that may still be in transit.

We sincerely apologise for any inconvenience caused and appreciate your full cooperation.

Should you require any further information, please contact us at 011 611 1400.

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.