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 particles in a 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, Lot No. 240605, was published on its website in error and should be ignored.
NAFDAC Director of Post-Market Surveillance Bitrus Fraden revealed this in a press conference on the regulatory clarification of the alert, saying that investigations into the complaint did not establish any non-conformity with Good Manufacturing Practice (GMP) requirements at the manufacturing facilities.
According to him, the complaint was filed by a pharmacist, Jiyah Dadi, whose pharmacy is located at No. 1, Aliyu Turaki, Isa Kaita Road, Malali, Kaduna, after purchasing the affected Deleject syringes from Zagbayi Pharmacy, Calabar Road, Kano Road, Kaduna.
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Fraden said NAFDAC traced the product through the distribution chain to the manufacturer, HMA, where the agency carried out an investigation and root cause analysis.
It said the investigation found that all manufacturing procedures had been followed and that an analysis of the manufacturer’s hold sample revealed no problems.
“Yes, the complaint came from a pharmacy called Jiyah, and Jiyah told us that she purchased that product from Zagbayi. We went to Zagbayi and Zagbayi said yes, it was supplied by the company. But going back to the facility where it was produced, all the procedures were followed, all the steps were followed, all the root cause analyzes were done and we couldn’t locate any errors coming from that site,” Fraden said.
He stressed that NAFDAC’s position was not intended to protect the manufacturer, saying the agency would have revealed any manufacturing defects if its investigation had established one.
“We’re not doing this because we want to protect the company. If there was a problem, I assure you, we would have told you clearly. We would have told you we traced it back to the facility,” he said.
Fraden explained that the problem could have occurred somewhere in the distribution chain, noting that a product manufactured in accordance with GMP requirements could still be compromised if handled incorrectly during transportation, storage or distribution.
He cited packaged food products as an example, saying that even a small puncture in a package or improper stacking could expose a product to air and render it defective despite being manufactured correctly.
According to him, the same principle inspired NAFDAC’s approach in investigating the Deleject complaint, examining the product at different stages before reaching its conclusion.
Fraden said NAFDAC also carried out nationwide surveillance of Deleject disposable needles following the Kaduna complaint, but found no similar reports from other parts of the country.
“Nationwide surveillance was carried out on this same product and we found that it was not widespread. It was just the incident that happened in Kaduna,” he said.
He explained that the affected products from the distributor and the pharmacy were cleaned after the complaint, adding that the agency acted with caution because laboratory analyzes had confirmed a problem with the particular product reported.
“It’s better for us to proceed with caution than to allow it to affect lives,” he said.
Fraden, however, said the investigation did not establish a specific violation that would justify sanctions against the distributor.
“When talking about sanctions, it must be established that the case is actually a violation that comes directly from an omission by the practitioner or whoever,” he said.
The NAFDAC director said the incident had highlighted the importance of proper handling and transportation of regulated products, warning that high-quality products could be compromised if exposed to inadequate storage or transportation conditions.
He revealed that NAFDAC was strengthening its track and trace system to enable the agency to monitor manufacturers’ products throughout the distribution chain and identify cases of diversion or mishandling.
“With traceability, the way we’re going, if at the end of the day when we have everything completed, I assure you even the diversion can be traced,” Fraden said.
He said the system would allow NAFDAC to track the movement of products, including vehicles transporting them from one city to another, while also allowing alerts to be generated when 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 called on Nigerians to continue reporting suspected quality or safety issues to NAFDAC, saying prompt reporting was essential to prevent 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 regulatory, quality or safety issues that would warrant an alert on commercially available Deleject disposable needle products, which have met applicable quality requirements and regulatory expectations.
NAFDAC therefore reassured healthcare providers, distributors, patients and the general public about the safety and quality of Deleject disposable needles in circulation, while regretting the publication of the alert.
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