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Class 3 Medicines Recall: Aspire Pharma Limited, Tropicamide 1% Eye Drops, solution in single dose containers 20 x 0.5ml , EL(26)A/47

Aspire Pharma Ltd is recalling specific batches of Tropicamide 1% Eye Drops, solution in single dose containers 0.5ml x 20, due to them being labelled with the incorrect expiry date. The correct expiry date for these batches should be 31/10/2026.

DMRC reference number

DMRC-41341621

Marketing Authorisation Holder

Aspire Pharma Ltd

Medicine Details

Tropicamide 1% Eye Drops, solution in single dose containers 20 x 0.5ml

PL: 35533/0198

Active ingredient: tropicamide

SNOMED code: 45542111000001107

GTIN: 5060209733661

Affected Lot Batch Numbers

Batch No. Expiry Date Pack Size First Distributed
E941A 30/04/2027* 20 29/10/2025
E941B 30/04/2027* 20 04/02/2026
E941C 30/04/2027* 20 20/02/2026

*Incorrect expiry date printed on packs

Background

Aspire Pharma Ltd is recalling the above specific batches of Tropicamide 1% Eye Drops, solution in single dose containers 0.5ml x 20, due to them being labelled with the incorrect expiry date. The correct expiry date for these batches should be 31/10/2026.

Advice for Healthcare Professionals:

Stop supplying the above batches immediately. Quarantine all remaining stock of these batches and return it to your supplier using your supplier’s approved process.

Advice for Patients:

No further action is required by patients. This recall is being undertaken as a precautionary measure at the Pharmacy and Wholesaler level.

Patients in possession of these batches should continue to use the eye drops and contact their prescriber to obtain a replacement prescription. No reports of adverse incidents due to this defect have been received to date.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Additional information:

For all medical information enquiries and information on this product, please email medinfo@aspirepharma.com, or telephone 01730 231148.

For stock control enquiries please email customerservices@aspirepharma.com, or telephone 01730 231148.

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.

Yours faithfully

Defective Medicines Report Centre

10 South Colonnade

Canary Wharf

London

E14 4PU

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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Class 3 Medicines Recall: Aspire Pharma Limited, Tropicamide 1% Eye Drops, solution in single dose containers 20 x 0.5ml , EL(26)A/47