Medicine Quality Alert: Class II Medicine Recall Of Zimycin 200mg/5ml (Azithromycin Dihydrate USP equivalent to Azithromycin 200 mg) Batch Number: ZIU022404
The Board has mandated Saga Laboratories, India to recall Zimycin (Azithromycin Dihydrate USP equivalent to Azithromycin 200 mg), Batch Number: ZIU022404
From: Pharmacy and Poisons Board
Date of Recall Initiation: 23rd December 2025
Recall Reference Number: REC/2025/037
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Saga Laboratories, India
Product name: Zimycin
Active Pharmaceutical Ingredient: Azithromycin Dihydrate USP equivalent to Azithromycin 200
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
ZIU022404
| 06/2024 | 05/2026.
| 15ml |
Brief description of the problem
The product did not meet the specification for assay. It was observed that the above-mentioned batch did not comply with the monograph specification with regard to Assay test.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing, or use of the above batch immediately. Await contact from the local technical representative, Pharmaken Limited, Kenya, to arrange the collection of the impacted batch.
Action for patients and caregivers
No further action is required by patients, as this is a Retail/hospital Pharmacy and Wholesaler/Distributor level recall. You are advised to talk to your healthcare professional if you have the above recalled batch of Zimycin (Azithromycin Dihydrate USP equivalent to Azithromycin 200 mg). The patients should continue taking other batches of the product, other than the impacted batch, and as prescribed by the healthcare professional.
Further Information
For inquiries about consignments of the impacted batch, please contact Pharmaken Limited, Kenya at nbi@pharmaken.net or by Telephone at: 0733244444
You are advised to promptly report any case(s) of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
- Mobile application: mPvERS both Android and iOS
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 II Medicine Recall Of Zimycin 200mg/5ml (Azithromycin Dihydrate USP equivalent to Azithromycin 200 mg) Batch Number: ZIU022404