MHRA Medicines Recalls

[helvella]

Today the MHRA have put out two recalls of medicines made in a specific Indian manufacturing plant.

No-one seems to think that there is any actual known issue with the medicines themselves. Therefore the recall is not intended to go out to patients. However, it is quite possible that there will be some transient supply issues.

There is only one medicine specific to thyroid disorder - Propylthiouracil from Wockhardt - though several of the medicines will undoubtedly be on the prescriptions of some here.

11 July 2013 Last updated at 13:23

Medicines watchdog recalls drugs made in India

The UK's medicines watchdog is recalling 16 prescription medicines made at an Indian factory which failed a routine inspection.

The Medicines and Healthcare products Regulatory Agency wants pharmacies to return stock of the drugs made by Wockhardt at its Waluj site.

The recalled drugs include some for diabetes, schizophrenia and thyroid conditions.

But the MHRA stresses there is no evidence of a risk to patient safety.

Some of the drugs include Metformin, taken by people with Type 2 diabetes; Atenolol, used to treat high blood pressure and angina; Pramipexole for Parkinson's disease; Risperidone for schizophrenia and Clopidogrel for blood clots.

Erythromycin, an antibiotic given to children which is made at the Waluj site but imported by a separate company, Pinewood Laboratories Ltd, is another of the 16 drugs being recalled.

The MHRA says people do not need to return their medicines and that it is important patients continue to take them as prescribed.

It says there are other versions of most of the recalled drugs made by a range of pharmaceutical companies.

And it said where other versions of the same medicines were not available, there were substitutes which doctors could prescribe,

A statement from the MHRA said it was not recalling the medicines people had at home because, although they had not been manufactured to Good Manufacturing Practice standards, there was no evidence of a patient safety risk from medicines that have been sold in the UK.

However, it said it had to act in the public interest - and poor manufacturing standards could not be allowed to continue.

Import tests

An inspection at the Waluj factory in March found some risk of cross-contamination because of poor cleaning practices, and defects in building fabric and the ventilation systems at the site.

There was also evidence of forged documents relating to staff training records that had been re-written.

The MHRA says it is working with Wockhardt and other international regulators to resolve the issue.

The full range of conditions treated by the 16 medications include infections, high blood pressure, diabetes, epilepsy, depression, schizophrenia, Parkinson's disease, dementia in Alzheimer's patients and thyroid conditions.

Gerald Heddell, the MHRA's director of inspection, enforcement and standards, said: "This is a precautionary recall.

"People can be reassured that there is no evidence that medicines made by Wockhardt are defective so it's important people continue to take their medicines as prescribed.

"All batches of medicines manufactured outside the European Union are tested on importation to the UK before they reach patients.

"However, we have taken this precautionary action because the medicines have not been manufactured to the right regulatory standards.

"We are working with the Department of Health to ensure that people have access to the medicines they need.

"Anyone who has questions should speak to their pharmacist or GP."

bbc.co.uk/news/health-23273101

mhra.gov.uk/Publications/Sa...

mhra.gov.uk/Publications/Sa...

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

Pinewood Laboratories Limited

Erythromycin 125mg/5ml sugar free granules for oral suspension PL 04917/0048

Erythromycin 250mg/5ml sugar free granules for oral suspension PL 04917/0049

Erythromycin 500mg/5ml sugar free granules for oral suspension PL 04917/0050

Rod

[LouiseRoberts]

Thanks Rod. Just replying to clear unanswered section.. xx