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Medicines defect noticeMHRA

Renacet 475 mg and 950 mg Tablets (calcium acetate) defect notice over a quality concern

Medicine quality concernLow riskClass 4

RenaCare NephroMed GmbH has informed the MHRA of the presence of an undeclared excipient in the coating of the tablets. This excipient is Macrogol 6000, which has always been included in Renacet Tablets but has been omitted from the list of excipients in error.

Check your product

Only products that match these details are covered. Have your pack in front of you.

30 identifiers listed for this notice.

  • Renacet 475 mg and 950 mg Tablets (calcium acetate), RenaCare NephroMed GmbH, EL(25)A15 200

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 2122403
    • 2122404
    • 2122405
    • 2122407
    • 2122408
    • 2122409
    • 2122410
    • 2222418
    • 2222419
    • 2222420
    • 2222421
    • 2222422
    • 2222439
    • 2222440
    • 2222441
    • 2222442
    • 2222443
    • 2222444
    • 2222445
    • 2222446
    • 2222447
    ExpiryOn the carton, blister or label.
    • 30/06/2027
    • 30/04/2027
    • 31/07/2027
    First distributedOn the product, its label or its packaging.
    • 30/01/2025
    • 05/03/2025
    • Not yet distributed
    • 11/02/2025
    • 07/03/2025
    • 27/03/2025

What to do now

A quality problem has been identified with Renacet 475 mg and 950 mg Tablets (calcium acetate), RenaCare.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the Yellow Card scheme.

Why it matters. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

Symptoms and when to get help

Look out for

  • a side effect you have not had before
  • your condition not being controlled as well as usual

Get help urgently

  • signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
  • if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111

This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.

Replacements and prescriptions

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.

An affected pack bought over the counter can be returned to where you bought it.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (class-4-medicines-defect-notification-renacet-475-mg-and-950). Quoted as issued.

Summary

RenaCare NephroMed GmbH has informed the MHRA of the presence of an undeclared excipient in the coating of the tablets. This excipient is Macrogol 6000, which has always been included in Renacet Tablets but has been omitted from the list of excipients in error.

The risk

DMRC reference number DMRC 35184448 Marketing Authorisation Holder

Advice for healthcare professionals

There has not been a change to the formulation of Renacet Tablets, prescribers should continue to provide these tablets to patients.

In very rare cases there are patients who are allergic to polyethylene glycols, with the possibility of minor allergic type reactions seen in patients who consume these ingredients orally. There have been very few reported adverse events associated with Renacet Tablets and the risk to patient health is minimal regarding this omission.

Macrogols are used in a range of pharmaceutical products as an excipient and at much higher doses, Macrogol is approved as a laxative in the UK at much higher quantities than are present in Renacet Tablets. This dose is far in excess of the dose consumed by patients who take Renacet as regular treatment.

Patients should continue to take tablets from these batches as prescribed by your healthcare professional.

If you are taking Renacet Tablets and have an allergy to Macrogol or to polyethylene glycol please notify your prescribing doctor.

In very rare cases oral macrogol or polyethylene glycols may cause allergic reactions. If you develop skin reactions including hives and itching, wheezing, a new cough, or nausea and vomiting please inform your doctor as soon as possible.

Any suspected adverse reactions should also be reported online via the Yellow Card scheme or via the Yellow card app available from the Apple App Store or Google Play Store.

Advice for patients

Patients should continue to take tablets from these batches as prescribed by your healthcare professional.

If you are taking Renacet Tablets and have an allergy to Macrogol or to polyethylene glycol please notify your prescribing doctor.

In very rare cases oral macrogol or polyethylene glycols may cause allergic reactions. If you develop skin reactions including hives and itching, wheezing, a new cough, or nausea and vomiting please inform your doctor as soon as possible.

Any suspected adverse reactions should also be reported online via the Yellow Card scheme or via the Yellow card app available from the Apple App Store or Google Play Store.

Open the MHRA notice

Questions

Why has Renacet 475 mg and 950 mg Tablets (calcium acetate), RenaCare been recalled?

A quality problem has been identified with Renacet 475 mg and 950 mg Tablets (calcium acetate), RenaCare. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

How do I know if my medicine is affected?

Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.

What should I do now?

Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.

Do I need a new prescription?

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.

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