The National Agency for Food and Drug Administration and Control (NAFDAC) has declared Deleject Disposable Needles safe for use following an investigation into a complaint of whitish particulate matter in one batch, saying there is no evidence of any manufacturing defect or safety risk associated with the products currently in circulation.
The agency also clarified that its Public Alert No. 042/2026 on Deleject Disposable Needles, Batch No. 240605, was published on its website in error and should be disregarded.
The Director of Post-Marketing Surveillance, NAFDAC, Bitrus Fraden, disclosed this at a press briefing on the regulatory clarification of the alert, saying investigations into the complaint did not establish any non-conformity with Good Manufacturing Practice (GMP) requirements at the manufacturing facility.
According to him, the complaint was lodged by a pharmacist, Jiyah Dadi, whose pharmacy is located at No. 1, Aliyu Turaki, Off Isa Kaita Road, Malali, Kaduna, after purchasing the affected Deleject syringes from Zagbayi Pharmacy, Calabar Road, Off Kano Road, Kaduna.
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Fraden said NAFDAC traced the product through the distribution chain to the manufacturer, HMA, where the agency conducted an investigation and root-cause analysis.
He said the investigation found that all manufacturing procedures had been followed and that an analysis of the manufacturer’s retention sample revealed no problem.
“Yes, the complaint came from a pharmacy called Jiyah, and Jiyah told us that he purchased that product from Zagbayi. We went to Zagbayi, and Zagbayi said yes, he was supplied by the company. But going back to the facility where this was produced, all the procedures, all the steps were followed, all root-cause analyses were done, and we couldn’t place any error coming from that site,” Fraden said.
He stressed that NAFDAC’s position was not intended to protect the manufacturer, saying the agency would have disclosed any manufacturing fault had its investigation established one.
“We are not doing this because we want to protect the company. If there was a problem, I assure you, we would have given you that clearly. We would have told you that we traced it to the facility,” he said.
Fraden explained that the problem could have occurred somewhere along the distribution chain, noting that a product manufactured in compliance with GMP requirements could still be compromised if improperly handled during transportation, storage or distribution.
He cited packaged food products as an example, saying even a minor puncture in a package or improper stacking could expose a product to air and render it defective despite being properly manufactured.
According to him, the same principle informed NAFDAC’s approach to investigating the Deleject complaint, with the agency examining the product at different stages before reaching its conclusion.
Fraden said NAFDAC also conducted nationwide surveillance of Deleject Disposable Needles following the Kaduna complaint but found no similar reports from other parts of the country.
“A nationwide surveillance was conducted on this same product, and we discovered it was not widespread. It was just that incident that happened in Kaduna,” he said.
He explained that the affected products from the distributor and pharmacy were mopped up after the complaint, adding that the agency acted cautiously because laboratory analysis had confirmed a problem with the particular product reported.
“It is better for us to act on the side of caution than to allow that to go on to affect lives,” he said.
Fraden, however, said the investigation did not establish a specific violation that could warrant sanctions against the distributor.
“When you talk of sanction, you have to establish that the case is actually a violation coming directly from either an omission by the practitioner or by whoever,” he said.
The NAFDAC director said the incident had highlighted the importance of proper handling and transportation of regulated products, warning that products of high quality could become compromised if exposed to inappropriate storage or transportation conditions.
He disclosed that NAFDAC was strengthening its track-and-trace system to enable the agency to monitor products from manufacturers through the distribution chain and identify cases of diversion or improper handling.
“With the traceability, the way we are going, if by the end of the day when we have everything completed, I assure you that even diversion can be traced,” Fraden said.
He said the system would enable NAFDAC to track the movement of products, including the vehicles conveying them from one city to another, while allowing alerts to be generated where products were exposed to conditions capable of compromising their quality.
Fraden urged distributors and other stakeholders to ensure that regulated products were transported in appropriate vehicles and stored under recommended conditions.
He also appealed to Nigerians to continue reporting suspected quality or safety concerns to NAFDAC, saying prompt reporting was essential to preventing potentially harmful products from reaching consumers.
He said NAFDAC remained committed to investigating consumer complaints and taking necessary regulatory action whenever evidence established a violation.
According to the agency, there are currently no quality, safety or regulatory issues warranting an alert on Deleject Disposable Needle products available on the market, which have met applicable quality requirements and regulatory expectations.
NAFDAC therefore reassured healthcare providers, distributors, patients and the general public of the safety and quality of Deleject Disposable Needles in circulation, while regretting the publication of the alert.
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