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