Class 2 Drug Alert (Action within 48 hours): Karib Kemi Pharm Limited - Multiple Product Drug Alert - Doxazosin 2mg and 4mg Tablets; Fluoxetine 20mg Capsules - EL (09)A/18

---

Dear Healthcare Professional,

 

Doxazosin 2mg Tablets (Doxazosin mesilate)

PL 18224/0029

Product in Karib Kemi Pharm Limited livery

Batch Number	Expiry Date	Pack Size	First Distributed
T1D 011007	09/2009	28	29/01/2008
T1D  010408	03/2010	28	16/05/2008
T1D 021108	10/2010	28	09/01/2009
T1D 010509	04/2011	28	29/02/2009
T1D 020509	04/2011	28	29/02/2009

 
Product in Consilient Health Limited livery

Batch Number	Expiry Date	Pack Size	First Distributed
T1D 010108	12/2009	28	07/03/2008
T1D 011108	10/2010	28	09/01/2009

 

Doxazosin 4mg Tablets (Doxazosin mesilate)

PL 18224/0030

Product in Karib Kemi Pharm Limited livery

Batch number	Expiry Date	Pack Size	First Distributed
T2D 010707	06/2009	28	20/12/2007
T2D 020707	06/2009	28	20/12/2007
T2D 010807	07/2009	28	07/04/2008
T2D 020807	07/2009	28	14/07/2008
T2D 010108	12/2009	28	14/07/2008
T2D 010208	01/2010	28	03/11/2008
T2D 010408	03/2010	28	21/10/2008
T2D 020408	03/2010	28	21/10/2008
T2D 040408	03/2010	28	17/11/2008
T2D 011108	10/2010	28	09/01/2009
T2D 010409	03/2011	28	26/05/2009
T2D 010509	04/2011	28	26/05/2009
T2D 020509	04/2011	28	29/02/2009
T2D 030509	04/2011	28	27/05/2009
T2D 040509	04/2011	28	27/05/2009
T2D 050509	04/2011	28	27/05/2009

 

Product in Consilient Health Limited livery

Batch number	Expiry Date	Pack Size	First Distributed
T2D 020108	12/2009	28	04/11/2008

 

Fluoxetine 20mg Capsules (Fluoxetine Hydrochloride)

PL 18224/0059

Product in Karib Kemi Pharm Limited livery

Batch number	Expiry Date	Pack Size	First Distributed
TF8 011208	11/2011	30	13/03/2009
TF8 021208	11/2011	30	01/04/2009
TF8 031208	11/2011	30	01/04/2009
TF8 041208	11/2011	30	01/04/2009
TF8 051208	11/2011	30	01/04/2009
TF8 010109	12/2011	30	27/05/2009
TF8 020109	12/2011	30	27/05/2009
TF8 030109	12/2011	30	27/05/2009
TF8 010209	01/2012	30	27/05/2009
TF8 020209	01/2012	30	27/05/2009
TF8 030209	01/2012	30	27/05/2009
TF8 040209	01/2012	30	08/06/2009

Karib Kemi Pharm Limited are recalling the above products due to serious Good Manufacturing Practice (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 Karib Kemi Pharm Limited on 07732 166641 or 07732 166891.

For enquiries related to stock returns and credit for products in Karib Kemi Pharm Limited livery please call Karib Kemi Pharm Limited on 07732 166641 or 07732 166891.

For enquiries related to stock returns for products in Consilient Health Limited livery please call 0208 9562697
For enquiries related to credit for products in Consilient Health Limited livery please call 00353 1 2057753

Recipients of this Drug Alert should bring it 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
Alison Bunce
Pharmaceutical Assessor, DMRC

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)