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

Medicines Healthcare Products Regulatory Agency

February 27
14:00 2023

CLMR Number

CLMR(23)A/03

MDR Number

MDR 187-02/23

Company name

Vertical Pharma Resources Ltd T/A IPS Pharma

Product name

Levothyroxine Oral Suspension (Various Strengths) [unlicensed medicine]

Product name Batch Number Expiry Date Pack Size First Distributed
LEVOTHYROXINE 25MCG IN 5ML SUSPENSION 230130125 04.03.2023 100ml 30.01.2023
LEVOTHYROXINE 50MCG IN 5ML S/F L/F G/F SUSPENSION 230124024 26.02.2023 100ml 24.01.2023
LEVOTHYROXINE 50MCG IN 5ML S/F L/F G/F SUSPENSION 230124025 26.02.2023 100ml 24.01.2023
LEVOTHYROXINE 50MCG IN 5ML S/F L/F G/F SUSPENSION 230124050 26.02.2023 100ml 24.01.2023
LEVOTHYROXINE 50MCG IN 5ML SUSPENSION 230124055 26.02.2023 100ml 24.01.2023
LEVOTHYROXINE 50MCG IN 5ML SUSPENSION 230127056 01.03.2023 100ml 27.01.2023
LEVOTHYROXINE 50MCG IN 5ML SUSPENSION 230201041 06.03.2023 100ml 01.02.2023
LEVOTHYROXINE 37.5MCG IN 5ML SUSPENSION 230202031 07.03.2023 140ml 02.02.2023
LEVOTHYROXINE 50MCG IN 5ML SUSPENSION 230202050 07.03.2023 150ml 02.02.2023
LEVOTHYROXINE 25MCG IN 5ML SUSPENSION 230202063 07.03.2023 100ml 02.02.2023
LEVOTHYROXINE 75MCG IN 5ML SUSPENSION 100ML 230202102 07.03.2023 100ml 02.02.2023
LEVOTHYROXINE 50MCG IN 5ML SUSPENSION 100ML 230206027 11.03.2023 100ml 06.02.2023
LEVOTHYROXINE 50MCG IN 5ML SUSPENSION 150ML 230206043 11.03.2023 150ml 06.02.2023
LEVOTHYROXINE 50MCG IN 5ML SUSPENSION 200ML 230206076 11.03.2023 200ml 06.02.2023
LEVOTHYROXINE 50MCG IN 5ML SUSPENSION 100ML 230209046 14.03.2023 100ml 09.02.2023
LEVOTHYROXINE 50MCG IN 5ML SUSPENSION 200ML 230210083 15.03.2023 200ml 10.02.2023
LEVOTHYROXINE 25MCG IN 5ML SUSPENSION 200ML 230210087 15.03.2023 200ml 10.02.2023
LEVOTHYROXINE 50MCG IN 5ML SUSPENSION 100ML 230215056 20.03.2023 100ml 15.02.2023
LEVOTHYROXINE 75MCG IN 5ML SUSPENSION 100ML 230220129 25.03.2023 100ml 20.02.2023

Active ingredient: levothyroxine

Brief description of the 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 products distribution.

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your suppliers 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 patients 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 patients 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 for 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 Contact for medical information enquiries

For medical information enquiries, please contact:

Amanda Peter

Tel: 0208 481 9720

amanda.peter@ips-pharma.com

Company Contact for stock enquiries

For stock information enquiries, please contact:

Felix Sanderson

Tel: 0208 481 9720

felix.sanderson@ips-pharma.com

Published 27 February 2023

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