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Two drug alerts issued

Accord Digoxin recall, SyreniRing advisory

August 5th 2020

Tagged: MHRA alert

By Charles Gladwin

Two drug alerts have been issued.

The first is a Class 3 recall for a batch of Accord-UK Ltd’s Digoxin Tablets BP 250 micrograms, 28s, with batch number XDG396 and expiry 11/2021, distributed since 26/03/2019.

Accord UK has advised that there are reports that when the pack is decommissioned in the pharmacy, scanning the serialised 2D code may show the pack status as ‘EXPORT’. Although there is no risk to product quality, any remaining stock should be quarantined and returned.

The second is a Class 4 level medical defect information regarding the patient information leaflet for SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system (3×1 packs) from Crescent Pharma Ltd.

The affected batches are:

  • LF18276AA, with expiry 08/2021, first distributed in March 2020
  • LF18894AA, with expiry 11/2021, first distributed in April 2020.

The PIL in these batches omits information under the warnings and precautions section about some users having reported depression or depressed mood and the potential risk of suicidal thoughts. The MHRA advises that if supplying the product, check the batch number and make sure the patient is aware of any missing information.