Class 4 Medicines Defect Information: Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL) (McNeil Products Limited)

Class 4 Medicines Defect Information: Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL) (McNeil Products Limited)

Drug alert number: EL (21)A/39

Date issued: 21 December 2021

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Class 4 Medicines Defect Information: Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL) (McNeil Products Limited)

McNeil Products Limited have identified an error relating to the stated alcohol content for batches of Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL) whereby the product labels understate the ethanol values. The products comply with the defined specifications, including ethanol content and, other than the incorrect ethanol content, all other label information is correct. However, the amount of ethanol contained within the products is low and hence the related on-pack safety warning, which reads “The small amount of alcohol in this medicine will not have any noticeable effects.”, is correct.

A table of the current (incorrect) and required (correct) labelling text can be seen below:

Products Licences Current labelling text (incorrect) Required labelling text (correct)
Benylin Chesty Coughs Original (P) PL 15513/0048 This medicine contains 0.26 mg of alcohol (ethanol) in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.  This medicine contains 197 mg of alcohol (ethanol) in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 5 ml beer or 2 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
Benylin Chesty Coughs Non-Drowsy (GSL) PL 15513/0056 This medicine contains 0.7 mg of alcohol (ethanol) in each 5 ml dose. The amount in a 5 ml dose of this medicine is equivalent to less than 1 ml beer or wine. The small amount of alcohol in this medicine will not have any noticeable effects. This medicine contains 197 mg of alcohol (ethanol) in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 5 ml beer or 2 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

Affected batches

Benylin Chesty Coughs Original (P)

Batch Number Expiry Date Pack Size First Distributed
V3879R 10/2023 300ml Not distributed yet
V3880R 10/2023 300ml Not distributed yet
V4017R 10/2023 300ml Not distributed yet
V4011R 10/2023 150ml Not distributed yet
V4016R 10/2023 150ml Not distributed yet

Active Pharmaceutical Ingredient: Diphenhydramine hydrochloride, Levomenthol

Benylin Chesty Coughs Non-drowsy (GSL)

Batch Number Expiry Date Pack Size First Distributed
V3366R 08/2024 300ml 03-Nov-2021
V3367R 09/2024 150ml Not distributed yet
V3371R 08/2024 150ml Not distributed yet
V3260R 09/2024 150ml Not distributed yet
V3621R 09/2024 150ml Not distributed yet
V3993R 10/2024 150ml Not distributed yet

Active Pharmaceutical Ingredient: Guaifenesin, Levomenthol

Advice for healthcare professionals

The impacted products are within specification and there is no issue with product quality. Despite the label error understating the ethanol content, the related label warning is correct. Therefore, the affected batches are not being recalled. Due to the products complying with the specifications, including ethanol content within the product, the batches on hold awaiting distribution will continue to be sold and have been included in this notification for information.

Since the products are within specification, there are no quality issues with the products and all safety warnings including the warning related to the alcohol content are correct, no specific action is required by healthcare professionals or retailers and this notification is being shared for information.

View full alert here

Further Information

For medical information queries please contact: McNeil Products Limited on 01344 864042 or by email to crc@its.jnj.com.

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