Class 3 Medicines Recall: Lynparza capsule 50mg (olaparib)
AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit. As a precautionary measure additional batches are also being recalled (EL(18)A/06)
Product information
MDR number
MDR 064-02/18
Company name
AstraZeneca
Product description
Lynparza capsule 50mg (olaparib)
EU/1/14/959/001
Batch number/expiry
| Batch Number | Expiry Date | Pack Size | First Distribution |
|---|---|---|---|
| NG327 | 31/10/2018 | 4 x 112 Caps | 13/10/2017 |
| NG143 | 30/11/2018 | 4 x 112 Caps | 19/07/2017 |
| NK719 | 30/06/2018 | 4 x 112 Caps | 12/10/2017 |
| NJ972 | 30/06/2018 | 4 x 112 Caps | 01/09/2017 |
| NR730 | 31/07/2018 | 4 x 112 Caps | 24/11/2017 |
| NK591 | 30/04/2018 | 4 x 112 Caps | 10/10/2017 |
| NR497 | 30/04/2018 | 4 x 112 Caps | 18/12/2017 |
Brief description of the problem
AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit. As a precautionary measure, the other batches listed are also being recalled as they may exceed the limit before the end of their shelf life.
Advice for healthcare professionals
Stop dispensing the batches listed above. Return all remaining stock of these batches to your supplier using the supplier’s approved process.
Wholesalers
Quarantine any remaining stock of these batches and return to the original supplier for credit.
Medical Information enquiries
For medical information enquiries please contact AstraZeneca Medical Information: 0800 783 0033 or medical.informationuk@astrazeneca.com
Stock enquiries
For stock availability queries please contact AstraZeneca Supply Chain: 0800 783 0033 or andy.bailey@astrazeneca.com
Download document
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional Teams are asked to forward this to community pharmacists, relevant clinics and dispensing general practitioners. It is not necessary to forward this notice to non-dispensing GPs.