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Medicine Quality Alert: Class II Recall of Diprofos Injection (Betamethasone Dipropionate and Betamethasone Sodium Phosphate), 7mg/ml 2ml AMP MEA

Organon South Africa (Pty) Ltd is recalling batches; W005050, W012878, W015902, W020203, W025759, W030457 & W032602 of Diprofos Injection due to the use of a potentially corroded component in the manufacturing of the products which creates the potential for stainless steel particulates in the formulations.

From: Pharmacy and Poisons Board

Published: 06 February 2023

Recall Reference Number: REC/2023/001

Recall Classification: Class II

Recall Level: Retail/Facility level

Manufacturer: Schering Plough Labo N.V., Belgium

Company Name: Organon South Africa (Pty) Ltd

Product name: Diprofos Injection

Active Pharmaceutical Ingredient: 6.43 mg Betamethasone dipropionate equivalent to 5 mg Betamethasone and 2.63 mg Betamethasone sodium phosphate equivalent to 2 mg Betamethasone per ml of solution

Affected Counties: All

Affected Batches

 

Batch Number

Date Of Expiry

Pack Size

1.     

W005050

24.05.2023

2ml

2.     

W012878

02.09.2023

2ml

3.     

W015902

09.09.2023

2ml

4.     

W020203

20.10.2023

2ml

5.     

W025759

18.11.2023

2ml

6.     

W030457

30.12.2023

2ml

7.     

W032602

13.03.2024

2ml

Brief description of the problem

Organon South Africa (Pty) Ltd is recalling batches W005050, W012878, W015902, W020203, W025759, W030457 & W032602 of Diprofos Injection due to the use of a potentially corroded component in the manufacturing of the product which creates the potential for stainless steel particulates in the formulations.

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing, and use of the affected batches immediately. You will be contacted by Imperial Managed Solutions to arrange for the return of the product.

Action for patients and caregivers

No further action is required by patients as this product is usually administered by healthcare professionals in a hospital setting, and the recall is a Retail/Hospital Pharmacy and Wholesaler/Distributor level recall.

Further Information

For stock inquiries please contact Imperial Managed Solutions by email at Quality.healthcare@imperiallogistics.com or via telephone at +254 719 059 178.

You are advised to promptly report any cases of adverse reactions and suspected substandard/falsified products to the nearest healthcare facility or through the following channels:

For any further information please contact the post-marketing surveillance unit at the Pharmacy and Poisons Board by email: pms@ppb.go.ke

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Medicine quality alert: Class II Recall of Diprofos Injection (Betamethasone Dipropionate and Betamethasone Sodium Phosphate), 7mg/ml 2ml AMP MEA