Class 4 Medicines Defect Information: Depo-Provera 150mg/ml Injection (Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder))

Class 4 Medicines Defect Information: Depo-Provera 150mg/ml Injection (Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder))

June 30, 2020

Class 4 Medicines Defect Information: Class 4 Medicines Defect Information: Depo-Provera 150mg/ml Injection (Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder))

Drug alert number: EL (20)A/26

Date issued: 30 June 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Class 4 Medicines Defect Information: Depo-Provera 150mg/ml Injection (Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder))

Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder) 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) however, it is stated as “methylpredinisolone acetate” (a corticosteroid) in error.

The product is packed as a single vial and is for administration by healthcare professionals. The outer carton and leaflets (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”.

Batch Number Expiry Date Pack Size First Distributed
AT0604 04/2023 1 22/04/2020
X44095 02/2023 1 21/02/2020

Advice for healthcare professionals

The above batches are not being recalled, as there are no concerns with the quality, safety and efficacy of the product. Existing stock at Drugsrus Ltd has been quarantined and no new stock will be released with the affected issue.

View full alert here

Further Information

For more information or medical information enquiries please contact info@drugsrus.co.uk or call on 020 8423 3800



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