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Class 2 Medicines Recall: Intrapharm Laboratories Ltd, Mydrilate 0.5% Eye Drops 5ml, EL (21)A/35

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 practicesPharmacyIssued:8 December 2021

Contents

  1. MDR Number
  2. Company name
  3. Product description
  4. Brief description of the problem
  5. Advice for healthcare professionals
  6. Further Information
  7. 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 NumberExpiry DatePack SizeFirst Distributed
YE096March 20225ml bottle6th 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.

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Class 2 Medicines Recall: Intrapharm Laboratories Ltd, Mydrilate 0.5% Eye Drops 5ml, EL (21)A/35

Published 8 December 2021

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-intrapharm-laboratories-ltd-mydrilate-0-dot-5-percent-eye-drops-5ml-el-21-a-slash-35?utm_medium=email&utm_campaign=govuk-notifications&utm_source=ae9c5b07-b1e0-4f64-bd26-24f1907b748f&utm_content=daily

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