Class 2 Drug Alert (Action within 48 hours): Jubilant Pharmaceuticals NV and Wockhardt UK Ltd - Amlodipine 5mg and 10mg Tablets - EL (09)A/15

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Dear Healthcare Professional,

Product distributed solely in Wockhardt UK livery

5mg Tablets
Batch Number	Expiry Date	Pack Size	First Distributed
T7A010508	04/2011	28 tablets	27/8/08
T7A020508	04/2011	28 tablets	11/9/08
T7A030508	04/2011	28 tablets	6/11/08
T7A040508	04/2011	28 tablets	2/12/08
T7A050508	04/2011	28 tablets	24/10/08

 

10mg Tablets
Batch Number	Expiry Date	Pack Size	First Distributed
T8A020508	04/2011	28 tablets	9/1/09

Jubilant Pharmaceuticals NV, the product marketing authorisation holder, are recalling the above products due to serious GMP deficiencies found during an inspection of their contract manufacturer.

All unused stock of the above batches should be quarantined and returned for credit.

For any Medical Information enquiries related to this case please call Jubilant Pharmaceuticals NV on 0032 487 209 973.

For enquiries related to stock returns and credit please call Wockhardt UK Customer Services on  01978  669215.

Recipients of this Drug Alert should bring this to the attention of relevant contacts by copy of this letter. Primary Care Trusts are requested to forward this to relevant clinics, General Practitioners and Community Pharmacists.

Yours faithfully
Ian Holloway
MHRA DMRC Manager

 

MHRA Distribution (further recipients by cascade):

Regional Contacts for NHS Trusts and Provider Units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to Independent Health Care Establishments
Primary Care Trusts (England)