Pregnancy tests, V-insertions products supplied by Honeybee found defective too

Pregnancy tests, V-insertions products supplied by Honeybee found defective too

PREGNANCY TEST KITS, MORNING AFTER PILLS, V- INSERTS SUPPLIED BY HONEYBEE ALSO FAKE, RECALLED

THE Zambia Medicines Regulatory Authority (ZAMRA) has written to Honeybee Pharmacy directing them to recall 19 more products from the market including pregnancy test kits and vaginal inserts.

In a letter dated January 28, 2021, addressed to Mr. Imran Lunat (the sole trader who was awarded the US$17 million Ministry of Health contract), ZAMRA Acting Director General Bonaventure Chilinde said the products should be withdrawn within 14 days.

“RE: RECALL OF MEDICINES WITH QUALITY DEFCTS IN THE RURAL HEALTH CENTRE KITS SUPPLIED TO MINISTRY OF HEALTH.

Reference is made to the above subject matter.

“The medicines were supplied to the Ministry of Health and delivered to Medical Stores Limited under the contract to supply Rural Health Centre.”

“The medicines were analyzed at our National Drug Quality Control Laboratory (NDQCL) and confirmatory tests undertaken at an ISO 17025 accredited and World Health Organisation (WHO) prequalified Laboratory for the Medicines Control Authority of Zimbabwe.”

“The products were found to be non-compliant with respect to acceptance criteria for various parameters that were tested based on the British Pharmacopoeia (BP 2020) and the United States Pharmacopoeia (USP42); refer to the laboratory test reports and the summary of defective products attached.”

“Therefore, you are directed to initiate an urgent RECALL of the affected batches from circulation within 14 days from the day of receipt of this letter,” read the letter.

“Use of press media with wide coverage is highly recommended.”

“You are further required to submit to the Authority a detailed report of the recall process which should include the quantities of the affected products imported and the quantities collected from the various health facilities and Medical Stores Limited.”

“You are instructed to notify the manufacturers of the products to conduct investigations and provide feedback on the product defects and any corrective and preventive actions (CAPAs) put in place to avoid recurrence of such defects in future”.

“We wish to inform you that we will closely monitor the recall to ensure that the products are completely removed from circulation in the interest of public health. Should you need further clarification please do not hesitate to contact the undersigned.”

In another letter, ZAMRA directed Honeybee Pharmacy to withdraw pregnancy test kits.

“RECALL OF HONEYBEE PREGNANCY TEST KITS IN HEALTH CENTRE KITS SUPPLIED TO MEDICAL STORES LIMITED.

Reference is made to the above subject matter.

The above mentioned kits were supplied to the Ministry of Health and delivered to medical Stores Limited under the contract to supply of rural health centre kits.

The kits were analyzed at the Pathology and Microbiology Department – MoH reference Laboratory at the University Teaching Hospital.

The pregnancy tests were found to be non-compliant with respect to test validation based on the comparison with the known performance-validated kit, ACON pregnancy test strips. Therefore, you are directed to initiate an urgent RECALL of the affected batches from circulation within 14 days from the day of receipt of this letter,” the letter read.

“Use of press media with wide coverage is highly recommended.”

“You are further required to submit to the Authority a detailed report of the recall process which should include the quantities of the affected products imported and the quantities collected from the various health facilities and Medical Stores Limited.”

“You are instructed to notify the manufacturers of the products to conduct investigations and provide feedback on the product defects and any corrective and preventive actions (CAPAs) put in place to avoid recurrence of such defects in future. We wish to inform you that we will closely monitor the recall to ensure that the products are completely removed from circulation in the interest of public health.”

“Should you need further clarification please do not hesitate to contact the undersigned.”

The following are some of the other products which have been recalled:

ACILIA (Lidocaine injection USP 2.0% w/v)

Clotrimazole vaginal inserts USP, 500mg

Paracetamol Tablets BP 500mg

Paracetamol Tablets BP 100 mg

Nystatin Oral Suspension BP, 100,00

Metronidazole Tablets USP 20mg

Nitrofurantoin tablets BP 50mg

Chlorpheniramine Maleate tablets BP 4mg

The medical products that have been recalled were distributed between September and October 2020.

Some of the products that have been recalled are replacements made after the first supply was recalled from health facilities.

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