| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00809-1 |
| Product Name/Description |
REFRESH NIGHT TIME and Ircal Eye Ointments
Ircal 2 x 3.5 g Ointment
Batch Number: 86908 (Exp: 12/17)
REFRESH NIGHT TIME 3.5 Ointment
Batch Numbers: 85422 (Exp: 06/17), 86516 (Exp: 09/17), 87052 (Exp: 11/17), 87437 (Exp: 02/18)
REFRESH NIGHT TIME 2 x 3.5g Ointment
Batch Numbers: 84683 (Exp: 04/17), 85422 (Exp: 06/17), 85432 (Exp: 06/17), 86514 (Exp: 9/17), 86934 (Exp:12/17)
ARTG Number: 187407 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
Allergan initiated this recall based on a small number of customer complaints regarding small black particles associated with the packaging of the product. This black particle, which is part of the cap, can be created by the action of unscrewing the cap from the aluminium tube, and potentially introduced into the ointment. If the particle gets into the eye, potential adverse events may include eye pain, eye swelling, ocular discomfort or eye irritation. |
| Recall Action |
Recall |
| Recall Action Instructions |
Allergan Australia Pty Ltd is advising the consumers, pharmacists and wholesalers to inspect their stock and immediately quarantine all the affected stock. Consumers will be offered a full refund for any affected product returned by them. Pharmacies have been requested to return their recalled stock to their wholesaler. Allergan Australia will coordinate the return transport from wholesalers and issue credit for the returned stock. This action has been closed-out on 06/09/23016. |
| Contact Information |
1800 252 224 - Allergan Customer Service |