Medicine Quality Alert: Class II Recall of Efinox 1% (Ephedrine Hydrochloride Nasal Drops) Batch Number 82979 and 82978
The Pharmacy and Poisons Board and Laboratory and Allied Limited have initiated the urgent recall of Efinox 1%, Batch No. 82979 and 82978 due to out-of-specification results on assay.
From: Pharmacy and Poisons Board
Published: 01/08/2024
Recall Reference Number: REC/2024/019
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Laboratory and Allied Limited
Product name: Efinox 1%
Active Pharmaceutical Ingredient: Ephedrine Hydrochloride Nasal Drops
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
82979 | 02/2023 | 01/2025 | 5ml bottle |
82978 | 02/2023 | 01/2025 | 5ml bottle |
Brief description of the problem
The product is being recalled following out-of-specification results (OOS) on assay.
Action for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and await contact from Laboratory and Allied Limited, Kenya, who will contact healthcare professionals directly to arrange the return.
Action for patients and caregivers
Patients currently prescribed Efinox 1% (Ephedrine Hydrochloride Nasal Drops) Batch No. 82979 and 82978, should be contacted by their prescribing healthcare professional. This is because you require a review with your prescribing healthcare professional to discuss alternative treatment options.
Further Information
For enquiries about consignments of the impacted batch, please contact Laboratory and Allied Ltd, at: pv@laballied.com, or via telephone: 0722877676, 0722406189
Promptly report any cases 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
For any further enquiries and feedback on the product recall, kindly contact the post-marketing surveillance unit of The Pharmacy and Poisons Board Kenya via email at pms@ppb.go.ke
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Medicine quality alert: Class II Medicine Recall of Efinox 1% (Ephedrine Hydrochloride Nasal Drops) Batch Number 82979, 82978