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Class 2 Drug Alert (Action Within 48 Hours): Multiple products - Wockhardt UK Limited (EL (13)A/19)

Document details:

Type: Drug Alert
Series No: EL (13)A/19
Audience: Healthcare professionals
Published: 11 July 2013
Format: Electronic only
Size: A4
Pages: 3
Copyright: Crown

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Action Within 48 Hours

Pharmacy, Clinic and Wholesaler Level Recall

11 July 2013 EL (13)A/19 Our ref: 

MDR 46-04/13

Dear Healthcare Professional,

Wockhardt UK Limited

Aciclovir 200mg Tablets PL 29831/0002
Aciclovir 400mg Tablets PL 29831/0001
Aciclovir 800mg Tablets PL 29831/0003
Atenolol 25mg Tablets PL 29831/0020
Atenolol 50mg Film-Coated Tablets PL 29831/0018
Atenolol 100mg Film-Coated Tablets PL 29831/0019
Clopidogrel 75mg Film-Coated Tablets PL 29831/0415
Donepezil Hydrochloride 10mg Film-Coated Tablets PL 29831/0441
Donepezil Hydrochloride 5mg Film-Coated Tablets PL 29831/0440
Entacapone 200mg Film-Coated Tablets PL 29831/0471
Levetiracetam 250mg Film-Coated Tablets PL 29831/0360
Levetiracetam 500mg Film-Coated Tablets PL 29831/0361
Levetiracetam 750mg Film-Coated Tablets PL 29831/0362
Levetiracetam 1000mg Film-Coated Tablets PL 29831/0363
Losartan 25mg Film-Coated Tablets PL 29831/0378
Losartan 50mg Film-Coated Tablets PL 29831/0379
Losartan 100mg Film-Coated Tablets PL 29831/0380
Metformin 500mg Film-Coated Tablets PL 29831/0133
Metformin 850mg Film-Coated Tablets PL 29831/0134
Pantoprazole 20mg Gastro-Resistant Tablets PL 29831/0372
Pantoprazole 40mg Gastro-Resistant Tablets PL 29831/0373
Pramipexole 88mcg Tablets PL 29831/0472
Pramipexole 180mcg Tablets PL 29831/0473
Pramipexole 350mcg Tablets PL 29831/0474
Pramipexole 700mcg Tablets PL 29831/0475
Propylthiouracil 50mg Tablets PL 29831/0179
Risperidone 0.5mg Film-Coated Tablets PL 29831/0343
Risperidone 1mg Film-Coated Tablets PL 29831/0344
Risperidone 2mg Film-Coated Tablets PL 29831/0345
Risperidone 3mg Film-Coated Tablets PL 29831/0346
Risperidone 4mg Film-Coated Tablets PL 29831/0347
Risperidone 6mg Film-Coated Tablets PL 29831/0348
Ropinirole 1mg Film-Coated Tablets PL 29831/0414
Sertraline 50mg Film-Coated Tablets PL 29831/0184
Sertraline 100mg Film Coated Tablets PL 29831/0183
Ursodeoxycholic Acid 300mg Film-Coated Tablets PL 29831/0198


All unexpired stock of the above products is being recalled to pharmacy, clinic and wholesaler level, irrespective of pack configuration, batch number and expiry date.

This is a precautionary recall following a routine inspection of the manufacturing site in India. The inspection identified deficiencies in good manufacturing practice (GMP) and the GMP certificate for this site has been withdrawn.

These products have been tested on importation and Qualified Person (QP) released. There is no evidence of a risk to patient safety from products currently in the UK market; however it is considered that the products have not been manufactured in line with GMP requirements.

No further products should be supplied. Products from alternatives suppliers are available in the majority of cases, either in equivalent strengths or varying strengths. Where there are no alternative suppliers therapeutic alternatives should be selected according to clinical practice.

Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit. For enquiries relating to stock returns please contact Wockhardt UK Ltd Customer services on 01978 669215 or email customer.services@wockhardt.co.uk.

For medical information enquiries please contact Wockhardt UK Ltd Medical Information on 01978 661261 or email drug.safety@wockhardt.co.uk.

MHRA is working with Wockhardt UK Ltd to ensure supply is resumed as quickly as possible; at this time there is no indication as to when new stock of these Wockhardt UK Ltd products is likely to be available.

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.

Yours faithfully

Adam Burgess
Defective Medicines Report Centre
151 Buckingham Palace Road
Telephone +44 (0)20 3080 6574

MHRA Distribution (further recipients by cascade): N/A
Page last modified: 11 July 2013