Company led medicines recall: Vertical Pharma Resources Ltd T/A IPS Pharma, Levothyroxine Oral Suspension (Various Strengths) [unlicensed medicine], CLMR(23)A/03

IPS Pharma is recalling specific batches of levothyroxine oral suspension from pharmacies and impacted patients due to the concentration of levothyroxine being greater than the amount stated on the label.

CLMR Number: CLMR(23)A/03

MDR Number: MDR 187-02/23

Company name: Vertical Pharma Resources Ltd T/A IPS Pharma

Product description: Levothyroxine Oral Suspension (Various Strengths) [unlicensed medicine]

Details of the affected batch:

Brief description of problem:

IPS Pharma is recalling specific batches of levothyroxine oral suspension from pharmacies and impacted patients due to the concentration of levothyroxine being greater than the amount stated on the label. The amount of levothyroxine in these bottles is reported to be ten times the labelled amount.

This recall is being issued as a company-led medicines recall as the products are only supplied to a limited number of patients, and the manufacturer can fully trace the product’s distribution.

Advice to Healthcare Professionals:

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

The pharmacies impacted by this recall have already been contacted directly and advised to contact patients and caregivers who have been dispensed the impacted product. Additionally, pharmacies have been advised to contact the patient’s doctor or healthcare professional responsible for their care to follow up with the patient as appropriate. The patient or caregiver should also be advised to contact and visit their doctor or prescriber responsible for their care, as soon as possible so that the patient can be checked and monitored, and so that a suitable alternative product may be prescribed for them.

IPS Pharma have confirmed that this issue dates back until October 2022, therefore they will be notifying all pharmacy teams and wholesalers who were previously supplied with impacted batches, to contact the patient’s doctor or healthcare responsible for their care to follow up with the patient as appropriate. IPS Pharma have confirmed that during this period no adverse events have been received.

Advice to Patients:

Patients and caregivers who have been dispensed the above batches of this unlicensed medicine will be contacted by the pharmacy team to arrange for alternative supply. If your doctor or healthcare professional responsible for your care has not contacted you, please arrange for a follow up appointment.

Patients who have been previously taking this product and have experienced, or experience any adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For medical information enquiries, please contact:

Amanda Peter Tel: 0208 481 9720 amanda.peter@ips-pharma.com

For stock information enquiries, please contact:

Felix Sanderson Tel: 0208 481 9720 felix.sanderson@ips-pharma.com