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Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Ltd, Paracetamol 250mg/5ml Oral Suspension (500ml) PL 00427/0078 EL (20)A/19

Published On:

30 March 2020

Published In:

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: [email protected]

Tel: 0113 244 1999

Medical queries

Email: [email protected]

Tel: 0113 244 1400

Product quality queries

Email: [email protected]

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.

Download the document

Class 4 medicines defect information: Rosemont Pharmaceuticals Ltd, Paracetamol 250mg/5ml Oral Suspension (500ml) PL 00427/0078 EL (20)A/19

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