Class 2 Medicines Recall: Cold & Flu Relief Capsules (GSL) – Various Liveries, Wrafton Laboratories Limited (trading as Perrigo), EL (21)A/28 - GOV.UK

MDR Number

MDR 055-11/21

Company name

Wrafton Laboratories Limited (trading as Perrigo)

Product description

Cold & Flu Relief Capsules (GSL) – Various Liveries PL 12063/0003

Wilko Non-Drowsy Decongestant with Paracetamol PL 12063/0003

Batch number Expiry date Pack size First distributed
9CW0032 Dec-21 16 23/04/2019
9DW0077 Jan-21 16 10/09/2019
9GW0048 Apr-22 16 14/10/2019
9LW0165 Sep-22 16 21/02/2020
0DW0072 Jan-23 16 24/04/2020
0EW0108 Feb-23 16 09/10/2020
0FW0086 Apr-23 16 07/10/2021

Spar Cold Relief Capsules PL 12063/0003

Batch number Expiry date Pack size First distributed
9CW0030 Dec-21 16 22/03/2019
9EW0009 Jan-22 16 30/09/2019
9MW0018 Aug-22 16 17/03/2020
0AW0013 Aug-22 16 30/01/2020
0DW0071 Jan-23 16 22/04/2020
0FW0081 Apr-23 16 17/05/202

Essential Waitrose Cold & Flu Relief Capsules PL 12063/0003

Batch number Expiry date Pack size First distributed
9KW0128 Aug-22 16 23/12/2019
0DW0092 Feb-23 16 05/05/2020
0GW0144 May-23 16 21/07/2020

Aldi Health Essentials Cold Relief Capsules PL 12063/0003

Batch number Expiry date Pack size First distributed
9FW0041 Mar-22 16 02/07/2019
9GW0049 Apr-22 16 27/08/2019
9HW0149 May-22 16 04/10/2019
0CW0186 Jan-23 16 17/09/2020
0GW0121 May-23 16 21/09/2020
0JW0055 May-23 16 14/10/2020

ASDA Cold Relief Capsules PL 12063/0003

Batch number Expiry date Pack size First distributed
9FW0065 Apr-22 16 17/07/2019
9GW0051 May-22 16 24/09/2019
9JW0005 Jul-22 16 19/11/2019
0AW0027 Sep-22 16 29/01/2020
0BW0098 Nov-22 16 03/03/2020
0CW0139 Nov-22 16 31/03/2020
0DW0093 Feb-23 16 24/09/2020
0FW0083 Apr-23 16 15/02/2021
0KW0008 Jul-23 16 01/10/2021

Superdrug Cold Relief Capsules PL 12063/0003

Batch number Expiry date Pack size First distributed
9CW0031 Dec-21 16 24/04/2019
9EW0069 Mar-22 16 01/08/2019
9HW0087 Jun-22 16 26/11/2019
0AW0111 Nov-22 16 23/03/2020
0CW0184 Jan-23 16 11/08/2020
0EW0109 Feb-23 16 04/09/2020

Superdrug Non-Drowsy Decongestant with Paracetamol PL 12063/0003

Batch number Expiry date Pack size First distributed
9EW0112 Mar-22 16 01/08/2019
0AW0016 Sep-22 16 23/03/2020
0DW0073 Jan-23 16 11/08/2020

Sainsbury's Healthcare Cold Relief Capsules PL 12063/0003

Batch number Expiry date Pack size First distributed
9DW0138 Jan-22 16 21/08/2019
9JW0006 Jul-22 16 24/10/2019
9KW0126 Aug-22 16 20/12/2019
0BW0096 Nov-22 16 05/03/2020
0DW0117 Feb-23 16 12/05/2020
1AW0059 Aug-23 16 28/05/2021

Sainsbury's Healthcare Sinus Dual Relief Capsules PL 12063/0003

Batch number Expiry date Pack size First distributed
9DW0075 Dec-21 16 17/05/2019
9HW0014 May-22 16 03/10/2019
9KW0127 Aug-22 16 03/02/2020
0AW0150 Sep-22 16 19/05/2020
0FW0084 Apr-23 16 15/12/2020
1DW0053 Feb-24 16 08/06/2021

Lloyds Cold Relief Capsules PL 12063/0003

Batch number Expiry date Pack size First distributed
9GW0050 Mar-22 16 09/09/2019
9MW0015 Aug-22 16 02/04/2020
0GW0143 May-23 16 16/09/2021

WM Morrison Cold Relief Capsules PL 12063/0003

Batch number Expiry date Pack size First distributed
9DW0076 Jan-22 16 23/09/2019
9HW0150 Jul-22 16 23/11/2019
0AW0151 Nov-22 16 24/02/2020
0EW0107 Feb-23 16 24/09/2020
0KW0007 Jul-23 16 18/08/2021
1JW0030 Jul-24 16 27/10/2021

Boots Cold & Flu Relief Capsules PL 12063/0003

Batch number Expiry date Pack size First distributed
9EW0113 Mar-22 16 03/09/2019
9FW0040 Mar-22 16 24/09/2019
9HW0026 Jun-22 16 07/10/2019
9HW0152 Jul-22 16 12/12/2019
9MW0017 Aug-22 16 07/03/2020
0AW0152 Nov-22 16 07/03/2020
0CW0183 Jan-23 16 22/09/2020
0DW0094 Feb-23 16 16/09/2021
0FW0087R Apr-23 16 24/09/2021

Boots Blocked Nose & Headache Relief Capsules PL 12063/0003

Batch number Expiry date Pack size First distributed
9FW0039 Mar-22 16 17/09/2019
9HW0027 Jun-22 16 07/10/2019
9KW0125 Aug-22 16 20/12/2019
0AW0015 Sep-22 16 13/03/2020
0CW0185 Jan-23 16 22/09/2020
0DW0091 Feb-23 16 20/10/2020
1JW0022 Feb-24 16 04/10/2021

Tesco Cold Relief Capsules PL 12063/0003

Batch number Expiry date Pack size First distributed
9BW0110 Dec-21 16 02/04/2019
9EW0021 Jan-22 16 17/07/2019
9HW0011 May-22 16 01/11/2019
9KW0123 Jul-22 16 19/12/2019
9MW0016 Aug-22 16 03/02/2020
0AW0014 Sep-22 16 27/02/2020
0BW0097 Nov-22 16 07/03/2020
0CW0141 Jan-23 16 06/04/2020
0DW0090 Jan-23 16 10/09/2020
0FW0088 Feb-23 16 05/05/2021
0KW0006 Jul-23 16 28/07/2021

Galpharm Cold Relief Capsules PL 12063/0003

Batch number Expiry date Pack size First distributed
9FW0064 Apr-22 16 03/09/2019
9HW0025 Jun-22 16 25/10/2019
9HW0151 Jun-22 16 13/11/2019
9KW0124 Jul-22 16 19/12/2019
9LW0164 Aug-22 16 03/02/2020
0AW0153 Nov-22 16 19/03/2020
0CW0140 Jan-23 16 06/04/2020
0DW0116 Feb-23 16 19/06/2020
0FW0085 Apr-23 16 14/10/2020
0GW0066 Apr-23 16 26/03/2021
0KW0066 Aug-23 16 02/09/2021

Active Pharmaceutical Ingredients: Paracetamol 300 mg, Caffeine 25 mg and Phenylephrine hydrochloride 5 mg

Brief description of the problem

Perrigo are recalling the above batches of Cold & Flu Relief Capsules (GSL) – Various Liveries, due to an error on the leaflet and carton for the products as noted above. The leaflet and carton incorrectly states that for Adults, the elderly and children 12 years and over, the dose should be 2 capsules every 4 to 6 hours as required, up to a maximum of 12 capsules in any 24 hour period. The leaflet and carton dosage instructions are those which were in use prior to the paediatric paracetamol posology update implemented by the MHRA.

As each capsule contains 300mg of paracetamol, 12 capsules would equate to 3.6g/day. This exceeds the MHRA recommended maximum dose for 12-15 year old's, which is 3g/day.

The correct posology instructions should state the following:

  • Adults and children 16 years and over: 2 capsules every 4 to 6 hours as required, up to a maximum of 12 capsules (6 doses) in any 24 hour period.
  • Children aged 12 to 15 years: 2 capsules every 4 to 6 hours as required, up to a maximum of 8 capsules (4 doses) in any 24 hour period.

This product is only sold from various retail stores directly and impacts all products that share the PL number, but packaged in different liveries. If you have any concerns, please contact Perrigo using the details below.

This recall is not directed to patient level due to the safety assessment on the short-term use of this product by children aged 12 to 15 years.

Advice for patients and consumers

  • Please refer to the correct dosage instructions listed above for Children aged 12 to 15 years.
  • If you experience any side-effects, or have any questions or concerns about your health, speak to your doctor or pharmacist.
  • Report any suspected side effects via the Yellow Card scheme

Advice for retailers and wholesalers

  • Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier's approved process.

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.
  • Any suspected side effects should be reported via the Yellow Card scheme

Further Information

For more information, please contact: Perrigo Customer Services Team

Tel: 0203 598 9603

Email: UKLOCustomerService@perrigo.com

For stock control queries, please contact: Perrigo Service Team

Tel: 01226 704711

Email: customerservice@perrigouk.com

Recipients of this Medicines Notification 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.

Download the document

Class 2 Medicines Recall EL (21)A/28

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