The MHRA has advised pharmacy and healthcare professionals to
return all remaining stock to their suppliers.
Crescent Pharma Limited is recalling one batch of Ramipril 5 mg
Capsules as a precautionary measure because
a potential manufacturing error may have
led to two blood pressure
medicines being packaged incorrectly.
This follows a complaint from a pharmacy after a patient reported
that a pack labelled Ramipril 5 mg Capsules (Batch
Number GR164099) contained blister strips of Amlodipine 5 mg
Tablets inside the sealed carton.
Both blood pressure medications are produced by
the same manufacturer, at the same site, and the error
appears to have occurred during secondary packaging of the
blister strips into the cartons.
Patients who take Ramipril are advised to check the
packaging of their medicine for batch
number GR164099 and return any containing blister strips
labelled “Amlodipine”
to their pharmacist.
The risk to patients of the accidental
substitution of one widely used blood pressure
medication for another is low. The most likely
side effect would be dizziness related
to low blood pressure.
Shareen Doak, Deputy Director, Benefit-Risk
Evaluation, at the Medicines and Healthcare products
Regulatory Agency (MHRA) said:
If you take Ramipril, check the packaging for batch
number GR164099. The batch number and expiry date
information can be found
on the outer carton. If you have
received this batch, check that
the medication name on the carton matches
the blister strips inside.
If the carton contains blister strips that are
labelled as Amlodipine 5 mg tablets, contact
your dispensing pharmacy. If the
carton contains blister strips that
are correctly labelled as Ramipril 5 mg
Capsules, you do not need to take further action.
If you have
an affected pack and think you may have
taken the Amlodipine 5 mg Tablets that
were supplied in error, and you are currently
experiencing any side effects, then please seek immediate
medical advice. Please take the leaflet that came with
your medicine and any remaining tablets with you to your pharmacy
or GP practice.
If you've already taken Amlodipine, please be
reassured that there is a very low risk
to your health. Both medications are used to treat
high blood pressure, however because your body may not be used to
a different type of medicine, your blood pressure may become
lower than normal, and you may experience dizziness because
of taking amlodipine. Any suspected adverse reactions
should also be reported via the MHRA Yellow Card scheme.
The MHRA has advised pharmacy and healthcare professionals
to return all remaining stock to their
suppliers.
Notes to editors
