MHRA recalls 16 POMs after contamination fears at Indian factory
Supply chain The MHRA has recalled 16 prescription-only medicines from pharmacies following fears of contamination at the site where they are manufactured, it announced today.
The MHRA has recalled 16 prescription-only medicines from pharmacies following fears of contamination at the site where they are manufactured, it announced today.
Fifteen of the medicines, which include treatments for high blood pressure, diabetes, epilepsy and dementia, are manufactured by Wockhardt UK Ltd at its site in Waluj, India. The antibiotic erythromycin, which has also been recalled, is manufactured by Pinewood Laboratories Limited at the same site.
A routine MHRA inspection in March found a "low risk of cross-contamination" because of poor cleaning practices and defects in the building and its ventilation systems, the medicines watchdog said.
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However, there was no evidence of a risk to patients, it said, advising therefore that they should continue to take their medicines.
The medicines, which vary in strength and include the diabetes drug metformin and the beta-blocker atenolol, had not been made to good manufacturing practice (GMP) standards and there was also evidence that staff training records had been re-written, the MHRA said.
Wockhardt UK Ltd managing director Sirjiwan Singh told C+D today that none of the faults found by the MHRA were "critical in nature" and re-iterated that there was no evidence of any risk to patient safety.
MHRA director of inspection, enforcement and standards Gerald Heddell 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 of 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," Mr Heddell added.
Mr Singh said that the site only produced 5 per cent of Wockhardt's UK products and he did not foresee any delays while these products were moved to another manufacturing site in India.
Most of the recalled medicines are available from alternative manufacturers in equivalent or varying strengths. The MHRA said that, if there was no alternative manufacturer, then healthcare professionals should select a substitute.
A full list of the recalled medicines is below:
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 |
|
Erythromycin 500mg/5ml sugar free |
DM11748 |
|
Erythromycin 250mg/5ml sugar free |
DM12089 |
|
Erythromycin 125mg/5ml sugar free |
DL12462 |
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