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| Level: | Retail |
|---|---|
| Class: | II |
| Reference: | RN-2008-0202 |
| Date agreed: | 26 March 2008 |
| Product: | HEPARINISED SALINE 50IU/5ml, packs of 50 ampoules |
| ARTG number: | 12107 |
| Batch number: | Batch Numbers 303364 Expiry Date: May 2009 Batch Numbers 303367 Expiry Date: May 2009 Batch Numbers 303601 Expiry Date: July 2009 Batch Numbers 303662 Expiry Date: August 2009 |
| Sponsor: | AstraZeneca Pty Ltd |
| Contact: | Astra Zeneca Customer Service 1800 805 342 |
| Reason: | The detection of a contaminant in the Heparin raw material used to manufacture these batches |
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.