MHRA Class 2 Medicines Recall: Intrapharm Laboratories Ltd, Mydrilate 0.5% Eye Drops 5ml

Drug alert number: EL (21)A/35

MDR Number: MDR 039-12/21

Date issued: 8th December 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall for Mydrilate 0.5% Eye Drops 5ml (Intrapharm Laboratories Ltd)

Brief description of the problem

Intrapharm Laboratories Ltd are recalling the below 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.

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.

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:, Contact number: 0330 1359 437

For stock control queries, please contact: Lauren Johnson, Commercial Affairs Manager, Intrapharm Laboratories Ltd, email:; Landline: 01628 771800.

View alert here.

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