The National Agency for Food and Drug Administration and Control (NAFDAC) has clarified that the Deleject Disposable Needle products in distribution in the country are in good and acceptable condition with no evidence indicating any quality or safety risk to healthcare providers, patients, distributors, or the public.

It noted that the Public Alert No. 042/2026, concerning the reported presence of whitish particulate matter in Deleject Disposable Needle Batch No. 240605, was uploaded onto the NAFDAC website in error.

Director of Post-Marketing Surveillance, NAFDAC, Bitrus Fraden who disclosed this on Friday in Abuja stated that the complaint that gave rise to the alert was lodged by Pharm. Jiyah Dadi, whose pharmacy is located at No. 1, Aliyu Turaki, Off Isa Kaita Road, Malali, Kaduna.

He noted that the complainant purchased the Deleject syringes in question from Zagbayi Pharmacy, Calabar Road, Off Kano Road, Kaduna.

Fraden pointed out that NAFDAC’s investigation of the manufacturing company, HMA, did not reveal any non-conformity with Good Manufacturing Practice (GMP) requirements

He said, The report may therefore be attributable to a supply chain challenge rather than a manufacturing defect.The matter had earlier undergone appropriate regulatory review and investigation and was satisfactorily resolved several months ago.

Fraden emphasized that there are currently no quality, safety, or regulatory issues that necessitate publication of the alert regarding Deleject Disposable Needle products available on the market.

“Deleject Disposable Needle products in distribution are in good and acceptable condition. These products have met the applicable quality requirements and regulatory expectations for use, with no evidence indicating any quality or safety risk to healthcare providers, patients, distributors, or the public.”

“The public healthcare providers, distributors, and other stakeholders are reassured of the quality and safety of the Deleject Disposable Needles. The publication is regretted and should be ignored,” he added.

Fraden pointed out that NAFDAC traced the product through the distribution chain to the manufacturer, HMA, where the agency conducted an investigation and root-cause analysis.

He observed that 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.

Fraden noted 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.

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.

Fraden said that 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 stated that NAFDAC is 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.

According to him, 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.