Class 4 Medicines defect information: Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL), EL(21)A/39
Error relating to the stated alcohol content for batches of Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL), supplied by McNeil Products Limited
MDR Number
MDR 021-12/21
Company name
McNeil Products Limited
Product description
Benylin Chesty Coughs Original (P)
| Batch No | 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 No | 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
Brief description of the problem
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. |
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.
Further Information
For medical information queries please contact: McNeil Products Limited on 01344 864042 or by email to crc@its.jnj.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.
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