| Level: | Consumer |
|---|---|
| Class: | II |
| Reference: | RC-2010-RN-00310-3 |
| Date agreed: | 27 March 2010 |
| Product: | AMLO 10 tablets (10mg amlodipine) Blister packs of 30 tablets |
| ARTG number: | 96962 |
| Batch number: | AR169 |
| Expiry | Nov 11 |
| Sponsor: | Spirit Pharmaceuticals Pty Ltd |
| Contact: | 1800 065 772 Spirit Medical Information |
| Reason: | This batch may contain AMLO 5 tablets (5mg amlodipine). |
Retail and hospital pharmacies were sent recall letters on 27 March 2010. Recall notices will appear in national newspapers from 31 March 2010.
Product Distribution: Retail and hospital pharmacies across Australia
Product export status: Not Exported
This action was first notified by Sponsor
Classification system:
Class I defects are potentially life-threatening or could cause a serious risk to health.
Class II defects could cause illness or mistreatment, but are not Class I.
Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.
Class I & II recalls are considered to be safety related recalls.