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Depo-Medrone with Lidocaine 40 mg/ml advisory issued

Outdated PIL included in five batches

April 27th 2022

Tagged: MHRA alert


Pfizer has advised that an outdated version of the Patient Information Leaflet (PIL) has been included in five batches of Depo-Medrone with Lidocaine (Methylprednisolone acetate and Lidocaine hydrochloride) 40mg/ml.

The affected batches in the Class 4 notification are:

  • EL4771 – 1ml
  • FK6842 – 1ml
  • EK3997 – 2ml
  • FK6089 – 2ml
  • FN9557 – 2ml

The outdated leaflet lacks warnings and precautions around:

  • peritonitis;
  • a risk of low birth weight.

In addition, the most recent leaflet (last revised 07/2021) updates the frequency of several possible side effects from ‘common’ to ‘not known’.

A copy of the current PIL is available here.