The Ministry of Food and Drug Safety (MFDS) has temporarily suspended sales and use of two batches of London-based pharmaceutical company GlaxoSmithKline’s (GSK) Boostrix vaccine following the discovery of a packaging defect. 

Boostrix is a prefilled syringe used to protect against tetanus, diphtheria, and pertussis (Tdap). 

In a safety notice issued last Friday, the MFDS said that the outer paper wrapper of disposable needles, included with the vaccine, was found to have a hole approximately 1 millimeter in diameter. 

Although the affected needles are encased in a protective cap, the agency decided to halt distribution as a precaution to minimize any microbial contamination risk.

The suspension applies to two specific batches of the Tdap vaccine imported by GSK in Korea, identified by manufacturing numbers AC37B455BN and AC37B467AI. They expire on Nov. 30, 2026, and March 31, 2027, respectively.

The MFDS has distributed a Drug Safety Bulletin to healthcare providers informing them of the issue, including doctors and pharmacists. The agency also emphasized the importance of prompt action in identifying the cause of the defect and monitoring for any related adverse reactions.

Wholesalers and medical institutions that possess the affected batches have been urged to comply with the suspension and report any abnormalities.

GSK Korea said it conducted an investigation at one of its vaccine manufacturing sites, following the discovery of a needle packaging defect in a small number of units, and remediation actions were in place.

"GSK has reported the incident to Korean regulators, including MFDS, and is closely discussing the situation," an official at GSK Korea said.