Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Ltd, Paracetamol 250mg/5ml Oral Suspension (500ml) PL 00427/0078 EL (20)A/19
Rosemont Pharmaceuticals Ltd has informed us of an error in the barcode and GTIN number of the label on the bottle of the below batches.
MDR Number
MDR 138-03/20
Company name
Rosemont Pharmaceuticals Limited (part of the Perrigo group)
Product description
Paracetamol 250mg/5ml Oral Suspension (500ml)
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 9AL0061 | 31.12.2020 | 500ml | Mar 2019 |
| 9CL0026 | 28.02.2021 | 500ml | Apr 2019 |
| 9DL0025 | 31.05.2021 | 500ml | Jun 2019 |
| 9EL0021 | 30.06.2021 | 500ml | Jul 2019 |
| 9GL0028 | 31.07.2021 | 500ml | Aug 2019 |
| 9JL0028 | 31.08.2021 | 500ml | Sept 2019 |
| 9JL0056 | 31.10.2021 | 500ml | Oct 2019 |
| 9KL0030 | 30.11.2021 | 500ml | Nov 2019 |
| 9LL0066 | 30.11.2021 | 500ml | Dec 2019 |
| 9LL0020 | 31.12.2021 | 500ml | Jan 2020 |
| 9ML0054 | 31.12.2021 | 500ml | Feb 2020 |
| 9ML0013 | 31.01.2022 | 500ml | Mar 2020 |
Brief description of the problem
Rosemont Pharmaceuticals Ltd has informed us of an error in the barcode and GTIN number of the label on the bottle of the above batches. When scanned, the barcode identifies the bottle as Paracetamol 120ml/5ml Oral Suspension instead of Paracetamol 250mg/5ml Oral Suspension. The dm&d browser website also identifies this GTIN number and barcode incorrectly as Paracetamol 120ml/5ml Oral Suspension.
The product is not subject to a recall and the strength printed on the bottle label is correctly stated as Paracetamol 250mg/5ml Oral Suspension. The barcode and the GTIN number on the outer box is correct and identifies the strength of the batches as Paracetamol 250mg/5ml Oral Suspension.
Action for healthcare professionals and patients
When identifying the product strength please go by the labelled contents’ not the strength stated when the barcode is scanned or the GTIN number on the dm&d browser website.
Advice for wholesalers
Please forward this letter on to any pharmacies, hospitals and healthcare professionals that you supply Paracetamol 250mg/5ml Oral Suspension to, within 5 days of receiving this letter.
Contact details for further information
Customer services queries
Email: Rosemont.customerservices@perrigouk.com
Tel: 0113 244 1999
Medical queries
Email: RosemontPharmacovigilance@perrigouk.com
Tel: 0113 244 1400
Product quality queries
Email: RosemontQAComplaints@perrigouk.com
Tel: 0113 244 1400
Additional information
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
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