On 28 May 2019, Macleods Pharmaceutical Ltd. notified WHO PQT: Medicines that an out-of-specification test result had been obtained on a product that was prequalified by WHO PQT: Medicines, TB342 Moxifloxacin Hydrochloride Dispersible Tablets 100 mg, batch No. BMC5801A.
The dissolution test results failed to meet the acceptance criteria of NLT 80 (Q) for 15 minutes at the S3 stage when stored under the condition of 30oC/75%RH (real time) for one of the commercial batches of TB342 Moxifloxacin Hydrochloride Dispersible Tablets 100 mg i.e. batch No. BMC5801A, manufactured on September 2018 (Expiry date: August 2020, Blister, Alu/Alu 10x10).
On 1 June 2019, Macleods Pharmaceutical Ltd. initiated a voluntary recall for this product. A health hazard assessment was performed by the company which established that there are no safety issues associated to the use of this product and that the therapeutic activity of Moxifloxacin dispersible tablets 100 mg was unlikely to be affected.
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