Class 2 Medicines Recall: Paracetamol 500mg Tablets, Chelonia Healthcare Limited, EL(25)A/25
Chelonia Healthcare Limited is recalling specific batches of Paracetamol 500mg Tablets (100 pots) as a precautionary measure due to contamination following a small number of complaints of discoloured tablets within the pots.
DMRC reference number
DMRC-35796576
Marketing Authorisation Holder
Chelonia Healthcare Limited
Medicine Details
Paracetamol 500mg Tablets
PL: 33414/0126
Active ingredient: Paracetamol
SNOMED code: 33554711000001108
GTIN: 05060014445506
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 2312010 | 30/11/2027 | 100 tablets (pots) | 14/04/2025 |
| 2312011 | 30/11/2027 | 100 tablets (pots) | 15/05/2025 |
Background
Chelonia Healthcare Limited is recalling Batch 2312010 of Paracetamol 500mg Tablets (POM) in Genesis livery as a precautionary measure following a small number of complaints of discoloured tablets found within some packs, reported by healthcare professionals.
This issue has only been identified in Batch 2312010, however as a precautionary measure, Batch 2312011 is also being recalled to mitigate any risk, as the investigation and analysis remain ongoing.
Advice for Healthcare Professionals:
Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier, using your supplier’s approved process.
Advice for Patients:
Patients or carers should check to see if they have received tablets from the listed batches of Paracetamol 500 mg Tablets. The batch number can be found on the label of the medicine bottle and on the outer carton. These tablets can only be obtained from a pharmacy with a prescription. The number of tablets you will have been given will vary depending on your prescription and you may have only received a small number of tablets.
The tablets should be ‘white capsule-shaped tablets, scored on one side’, as per the Patient Information Leaflet (PIL). If you find tablets that are discoloured in any way, in pots from the listed batches, please contact your pharmacist or the healthcare professional who dispensed your prescription. Patients who experience 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.
Additional information:
For all medical information enquiries and information on this product, please email eupvg@genreg.eu or telephone 020 7201 0421.
For stock control enquiries please email info@genesis-pharma.com or telephone 0207 201 0400.
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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