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Medicine Quality Alert: Class III Medicine Recall of Para-Denk 125mg Suppos and Para-Denk 250mg, suppositories

Denk Pharma GmbH & Co. KG has initiated an urgent voluntary recall of Para-Denk 125mg and 250mg Suppos for the batches listed below.

From: Pharmacy and Poisons Board

Date of Recall Initiation: 9th July 2025

Recall Reference Number: REC/2025/021

Recall Classification: Class III

Recall Level: Wholesaler/Distributor level

Manufacturer: RubiePharm Arzneimittel GmbH, Germany

Local Technical Representative: Laborex Kenya Limited

Other Distributors: Omaera Pharmaceuticals Ltd and Symbio Healthcare Ltd

Product name: Para-Denk 125mg Suppos and Para-Denk 250mg Suppos

Active Pharmaceutical Ingredient: Paracetamol 125mg and Paracetamol 250 mg Suppository

Affected counties: All

Affected Batches

Batch Number

Strength

Date of Expiry

Pack Sizes

28426

250 mg

31.03.2027

10’s

28579

250 mg

31.03.2026

10’s

26906

125 mg

31.07.2025

10’s

27286

125 mg

31.01.2026

10’s

27339

125 mg

31.03.2026

10’s

27342

125 mg

31.05.2026

10’s

27846

125 mg

30.11.2026

10’s

27836

250 mg

30.11.2026

10’s

28422

250 mg

28.02.2027

10’s

28424

250 mg

28.02.2027

10’s

28420

125 mg

28.02.2027

10’s

28458

125 mg

30.04.2027

10’s

27670

125 mg

31.05.2026

10’s

27672

125 mg

30.06.2026

10’s

27291

250 mg

31.12.2025

10’s

27343

250 mg

28.02.2026

10’s

27674

250 mg

31.03.2026

10’s

27821

250 mg

30.06.2026

10’s

27822

250 mg

30.06.2026

10’s

Brief description of the problem

The product is being recalled due to packaging damage, causing leakages in some batches of the suppositories.

Action for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and await contact from Laborex Kenya Limited to arrange the return.

Action for patients and carers

No further action is required by patients as this is a Wholesaler/Distributor level recall.

Further Information

For inquiries about consignments of the impacted batches, please contact Laborex Kenya Limited at ssavla@laborex-healthcare.com or via telephone at +254 (0) 20 69 39 162 or +254 769 579 060, Omaera Pharmaceuticals Ltd at: omaera@africaonline.co.ke, +254 728 970 777, +254 722 701 312, and Symbio Healthcare Ltd at: steve.denk@yahoo.com or Tel +254 722 203 050

Promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:

For any further enquiries and feedback on the product recall, contact the post-marketing surveillance unit at the Pharmacy and Poisons Board via email at pms@ppb.go.ke

 

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Medicine Quality Alert: Class III Recall of Para-Denk 125mg Suppos and 250mg Suppos, suppositories

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