Class 3 Medicines Recall: Lynparza capsule 50mg (olaparib)
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