Class 3 Medicines Recall: Intrapharm Laboratories Ltd, Kolanticon Gel 500ml, EL (21)A/01
Intrapharm Laboratories Ltd has informed us that they have received complaints that the consistency of a batch of Kolanticon Gel 500ml is lumpy. An investigation and retained samples for this batch show the same homogeneity issue.
PL Number(s)
PL 17509/0084
MDR Number
MDR 349-01/21
Company Name
Intrapharm Laboratories Ltd
Product description
Kolanticon Gel 500ml
- Batch number: AC0620
- Expiry date: 31/12/2021
- Pack size: 1 x 500ml
- First distributed: 23/11/2020
Active Pharmaceutical Ingredients: dicycloverine hydrochloride, aluminium hydroxide, light magnesium oxide, simethicone
Brief description of the problem
Intrapharm Laboratories Ltd has received a number of complaints that the product consistency is lumpy. The investigation has confirmed through review of the retained samples that the consistency of the complaint samples are similar and the retained samples for this batch show the same homogeneity issue.
Advice for healthcare professionals
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Further Information
For more information or medical information queries, please contact: medinfo@intrapharmlabs.com or telephone +44 (0)330 1359 437.
Recipients of this Drug Alert 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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