NAFDAC Places FORTCEF Ceftazidime Injection Batches on Hold After Reports of Serious Adverse Events

The National Agency for Food and Drug Administration and Control (NAFDAC) has placed two batches of FORTCEF Ceftazidime Injection 1 g on hold following reports of serious and potentially life-threatening adverse events, including three reported fatalities among cases currently under investigation.

In a Dear Healthcare Provider communication dated 14 September 2026, NAFDAC identified the affected batches as PFZIE001 and OFZIE001 and advised healthcare professionals and members of the public to discontinue the purchase, sale, administration and use of the implicated batches pending the outcome of ongoing pharmacovigilance and quality investigations.

What NAFDAC is investigating

According to the agency, reports received from healthcare facilities in multiple locations described acute events occurring following administration of FORTCEF Injection. These included vomiting, chest pain, confusion, loss of consciousness, restlessness, gasping, flaccidity and unresponsiveness.

NAFDAC said three fatalities had been reported among the cases under investigation. However, the agency has not stated that FORTCEF or ceftazidime has been confirmed as the cause of the deaths.

The reports have so far implicated batches PFZIE001 and OFZIE001, prompting the regulatory investigation.

This distinction is important in interpreting the alert. A pharmacovigilance report identifies a suspected association that requires assessment; it does not, by itself, establish that a medicine caused an adverse event.

Which product is affected?

NAFDAC identified the affected product as:

• Product: FORTCEF Ceftazidime Injection 1 g

• Active ingredient: Ceftazidime 1 g

• Dosage form: Powder for injection

• NAFDAC registration number: C4-0247

• Affected batches: PFZIE001 and OFZIE001

• Manufacturing date: May 2025

• Expiry date: April 2028

• Manufacturer: LABORATE Pharmaceuticals, India

• Marketed by: Embassy Pharmaceutical and Chemicals.

NAFDAC's Greenbook independently lists FORTCEF 1 g Injection as a ceftazidime product under registration number C4-0247.

NAFDAC raises separate concern over registration status

The safety investigation comes alongside a regulatory issue concerning the product's registration.

NAFDAC said its review of FORTCEF's regulatory status showed that the product was initially registered in 2019 with an approved registration expiry date of December 2024. According to the agency, available records show no evidence of renewal of the product's registration in NAPAMS after the registration period expired.

This does not mean that every ceftazidime injection on the Nigerian market is affected. The NAFDAC communication specifically identifies the FORTCEF product and the two batches named in the notice.

What healthcare facilities have been asked to do

NAFDAC has instructed healthcare facilities to quarantine and segregate available stock belonging to the affected batches.

Facilities have also been directed to retain the affected products, including the vials, packaging and other relevant materials, for possible investigation.

Importantly, NAFDAC says the affected products should not be discarded while the investigation is ongoing.

Healthcare providers and patients have also been urged to exercise caution within the medicines supply chain and avoid the purchase, sale, administration or use of the batches placed on hold.

Ceftazidime remains an established antibiotic

Ceftazidime is a third-generation cephalosporin antibiotic used to treat susceptible bacterial infections. NAFDAC's Greenbook lists ceftazidime among third-generation cephalosporins and lists several ceftazidime-containing products.

The regulatory action against the specified FORTCEF batches should therefore not be interpreted as a withdrawal of ceftazidime as an antibiotic generally.

Ceftazidime, like other medicines, has recognised adverse effects and safety precautions. Official prescribing information describes hypersensitivity reactions, neurological reactions and other adverse effects, while noting that some serious reactions reported after marketing cannot always be assigned a definite causal relationship to the medicine.

What happens next?

NAFDAC's investigation is expected to determine whether the reported events are associated with the implicated batches and whether quality or other factors contributed to the cases.

Until the investigation is concluded, healthcare facilities should follow NAFDAC's instruction to quarantine the affected batches and retain the products and associated packaging for possible investigation.

Healthcare professionals and patients who suspect an adverse reaction associated with the product can report it to NAFDAC through its pharmacovigilance reporting channels. The agency lists its e-reporting platform, Med Safety application and pharmacovigilance email as reporting routes.

Pharmacy Times Nigeria will continue to follow the regulatory investigation and report any further information released by NAFDAC.