The Medicines and Health products Regulatory Agency (MHRA) has issued a class four medicines defect information notice for Depo-Provera 150mg/ml injection.
The marketing authorisation holder, Tenolol Ltd, has informed MHRA of a typographical error in active ingredient stated on the label on the vial.
The active ingredient should be “medroxyprogesterone acetate” (a long acting contraceptive) instead of it “methylpredinisolone acetate” (a corticosteroid).
The product is packed as a single vial and is for administration by healthcare professionals.
“The outer carton and leaflets or patient leaflet and healthcare professional leaflet have the correct active ingredient-medroxyprogesterone acetate stated on them, and the brand name on the vial is also correctly stated as “Depo-Provera”,” the MHRA has said.
Community pharmacists have been advised that the two batches are not being recalled, as there are no concerns with the quality, safety and efficacy of the product.
Existing stock at drug distributer Drugsrus Ltd has been quarantined and no new stock will be released with the affected issue.
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