Wockhardt recall in UK
July 15, 2013
BRITISH pharmaceutical
regulators have ordered the
precautionary recall of a range of
Wockhardt Limited prescription
medicines sold in the UK, after the
identification of manufacturing
deficiencies at the company’s site in
Waluj, India.
At this stage it’s not a consumerlevel
recall, but all unexpired
stock of the medications is being
recalled to pharmacy, clinic and
wholesaler level, irrespective of
pack configuration, batch number
and expiry date.
The Medicines and Healthcare
products Regulatory Agency
(MHRA) inspection identified
deficiencies in good manufacturing
practices at the Indian plant, with
the GMP certificate for the site
having been withdrawn.
The MHRA said it had identified
a risk of cross-contamination
because of poor cleaning practices
and defects in ventilation systems,
as well as evidence of forged
documents relating to staff training
records that had been rewritten.
There’s no evidence at this
stage of a patient safety risk,
with medicines affected by the
precautionary recall in the UK not
specifically identified as defective.
“However the MHRA has to act
in the interests of public health
as poor manufacturing practices
cannot be allowed to continue,” the
regulator said.
Affected Wockhardt products
include aciclovir, atenolol,
clopidogrel, donepezil, entacapone,
levetiracetam, losartan, metformin,
pantoprazole, pramipexole,
propylthiouracil, risperidone,
ropinirole, sertraline and
ursodeoxycholic acid.
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