Class 4 Medicines Defect Notification: Renacet 475 Mg And 950 Mg Tablets (calcium Acetate), Renacare Nephromed Gmbh, El(25)a15
Renacet 475 mg and 950 mg Tablets Recall Summary Renacet calcium acetate tablets (475 mg and 950 mg strengths) are being recalled in the United Kingdom because an ingredient called Macrogol 6000 in the tablet coating was not listed on the product information, even though it has always been present in the tablets. The manufacturer omitted this ingredient from the excipients list by error. This recall affects patients in the United Kingdom who are taking these tablets.
- Recalling firm
- Renacet 475 mg and 950 mg Tablets (calcium acetate)
- Reason
- 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.
- Classification
- Class III
- Category
- drug recall
- Country
- United Kingdom
- Agency
- UK Medicines and Healthcare products Regulatory Agency
- Recall date
- 2025-04-07
- Status
- Ongoing
- Distribution
- United Kingdom
Official recall notice from UK Medicines and Healthcare products Regulatory Agency
Recall details on Nibble Recalls: https://trynibble.app/recalls/09c13a03-493c-42c6-bb6c-4637a106cd54