Viread 245 mg Film-Coated Tablets - possible presence of silicone rubber

(Gilead Sciences Limited) Pharmacists should quarantine any remaining stocks affected batches and return them to the original wholesaler for credi - class 2 action within 48 hours. (EL (14)A/03)

06 March 2014

Class 2 medicines recall

Action within 48 hours

Pharmacy, dispensing clinic and wholesale level recall

MDR 07-03/14

Product details

Gilead Sciences Limited

Viread 245 mg Film-Coated Tablets

(Tenofovir disoproxil fumarate)

EU/1/01/200/001-002

Alert details

Batch number   Expiry date   Pack size   First distributed
KFBSD   December 2017   30 film-coated tablets   31 January 2014
KFBTD   December 2017   30 film-coated tablets   16 October 2013

Gilead Sciences Limited is recalling the above batches of Viread 245 mg Film-Coated Tablets due to the possible presence of silicone rubber. A failure of equipment used in the manufacture of the active pharmaceutical ingredient formulated in these medicinal product batches may have resulted in damage to silicone gaskets and silicone fragments entering the product in these recalled lots. 

Pharmacists are asked to quarantine any remaining stocks of the above batches and return them to the original wholesaler for credit. For stock enquiries please contact Gilead Sciences Customer Services on 01223 897400.

For medical information enquires please contact Gilead Sciences Ltd Medical Information at 01223 897555 or by email to ukmedinfo@gilead.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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