Class 2 Medicines Recall: Tesco Flu-Max All In One Chesty Cough & Cold Powder for Oral Solution Wrafton Laboratoires Limited (trading as Perrigo) EL (21)A/24
Perrigo are recalling batches of Tesco Flu-Max All In One Chesty Cough & Cold Powder due to an error on the sachet contained within the outer carton.
Company name
Wrafton Laboratoires Limited (trading as Perrigo)
Tesco Flu-Max All In One Chesty Cough & Cold Powder for Oral Solution (GSL) PL 12063/0104
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 9MW0145 | Nov 2022 | 10s | 16 Mar 2020 |
| 0CW0054 | Jan 2023 | 10s | 07 Apr 2020 |
| 0FW0133 | May 2023 | 10s | 12 May 2021 |
Active Pharmaceutical Ingredients: Paracetamol 1000 mg/sachet; Guaifenesin 200 mg/sachet; Phenylephrine hydrochloride 12.2 mg/sachet
MDR number
MDR 098-10/21
Brief description of the problem
Perrigo are recalling the above batches due to an error on the sachet contained within the outer carton. The sachet artwork incorrectly states that children aged 12 years and over can take 4 sachets containing 1000mg of paracetamol (i.e. 4 doses over a 24 hour period), whereas the carton, PIL and SmPC state that the product is not to be given to the under 16s. The sachets dosage instructions are those which were in use prior to the paediatric paracetamol posology update implemented by the MHRA.
The correct posology instruction on the outer carton, patient information leaflet (PIL) and summary of product characteristics (SmPC) comply with regulatory requirements but differ from that on the product sachet which is incorrect. See link to PIL containing the correct information.
This product should not be given to under 16s and therefore the product is being recalled from patients directly.
This product is only sold from Tesco stores directly and does not impact any other products that share the PL number, but packaged in different liveries. If you have any concerns, please contact Perrigo using the details below.
Advice for patients and consumers
- Stop using the product immediately and return this to Tesco Stores.
- 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
- Advise patients who have been supplied this product to stop using the product immediately and return this to Tesco Stores, where appropriate.
- Any suspected side effects should be reported via the Yellow Card Scheme.
Further Information
For more information, please contact: Perrigo Customer Services Team on 0203 598 9603 or [email protected]
For stock control queries, please contact: Perrigo Service Team on 01226 704711 or [email protected]
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.
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