Natzon 0.4mg Sublingual Tablets - wrong blister packs in cartons

(Morningside Healthcare Limited) Small number of blisters containing Buprenorphine 8mg Sublingual Tablets packed in cartons labelled Natzon 0.4mg Sublingual Tablets – class 2 action within 48 hours. (EL (13)A/23)

26 September 2013

Class 2 medicines recall

Action within 48 hours

Patient and pharmacy-level recall

MDR 49-09/13

Product details

Morningside Healthcare Limited

Natzon 0.4mg Sublingual Tablets

Buprenorphine

PL 20117/0209

Alert details

Batch number   Expiry date   Pack size   First distributed
13D22   April 2016   1 x 7   12 August 2013
13D24   April 2016   1 x 7   22 August 2013

Morningside Healthcare Limited has informed the MHRA that a small number of blisters containing Buprenorphine 8mg Sublingual Tablets from batch number 13D22 have inadvertently been packed in cartons labelled Natzon 0.4mg Sublingual Tablets with the same batch number, 13D22. The incident is thought to have occurred due to an error at the printers and since the cartons for batch 13D24 were from the same printers’ batch, batch 13D24 is being included in the scope of the recall as a precaution.

Pharmacists and dispensing doctors are asked to check the batch numbers of stocks of Natzon 0.4mg Sublingual Tablets. Any cartons embossed with the batch numbers 13D22 and 13D24 should be quarantined and returned via the original supplier for credit. Patients who may have received these batches should be contacted and asked to return any affected stock.

Please note that cartons of Buprenorphine 8mg Sublingual Tablets with the same batch numbers (13D22 and 13D24) are not included in this recall and should not be returned.

For stock return enquiries, please contact Customer Services Team on 01509 217705 or email at sales@morningsidepharm.com

For medical information enquiries, please contact Medical Enquiries on 0845 459 2137 or email at medicalenquiry@morningsidehealthcare.com

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

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