Class 2 Medicines Recall: Intrapharm Laboratories Ltd, Mydrilate 0.5% Eye Drops 5ml, EL (21)A/35
December 9, 2021
Intrapharm Laboratories Ltd are recalling the above batch of Mydrilate 0.5 % Eye Drops 5ml as a precautionary measure due to out of specification results for related substances obtained during stability testing.
obtained during stability testing.From:Medicines and Healthcare products Regulatory AgencyPublished8 December 2021Alert type:Medicines recall/notificationMedical specialty:Dispensing GP practices, PharmacyIssued:8 December 2021
Contents
- MDR Number
- Company name
- Product description
- Brief description of the problem
- Advice for healthcare professionals
- Further Information
- Download document
MDR Number
MDR 039-12/21
Company name
Intrapharm Laboratories Ltd
Product description
Mydrilate 0.5% Eye Drops, 5ml, (PL 17509/0007)
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| YE096 | March 2022 | 5ml bottle | 6th July 2020 |
Active Pharmaceutical Ingredient: Cyclopentolate Hydrochloride Ph.Eur.
Brief description of the problem
Intrapharm Laboratories Ltd are recalling the above batch of Mydrilate 0.5 % Eye Drops 5ml as a precautionary measure due to out of specification results for related substances obtained during stability testing.
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: Redline Pharmacovigilance, email: medinfo@intrapharmlabs.com, Contact number: 0330 1359 437
For stock control queries, please contact: Lauren Johnson, Commercial Affairs Manager, Intrapharm Laboratories Ltd, email: Lauren.Johnson@riemser.com; Landline: 01628 771800.
Recipients of this Medicines Recall 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 document
Class 2 Medicines Recall: Intrapharm Laboratories Ltd, Mydrilate 0.5% Eye Drops 5ml, EL (21)A/35
Published 8 December 2021
