MERCK Vaxneuvance (PCV15) Vaccine recall

Oakland County, Michigan sent this bulletin at 01/17/2024 09:54 PM EST

This email is being sent to VFC, Non-VFC and Covid-19 Providers in Oakland County, Michigan by the Oakland County Health Division (OCHD) Immunization Action Plan (IAP)

mdhhs

Dear Immunization Partners,

Please share the following information with all staff and colleagues.

Merck has initiated a voluntary recall for the following 10 lots of Merck’s VAXNEUVANCE™ (NDC# 00006-4329-03) in the US market:

  • W037992,
  • W027275,
  • W036242,
  • W039033,
  • X004289,
  • X005583,
  • X011328,
  • X011332,
  • X012044, and
  • X011735

Merck has received reports of breakage at the syringe flange and/or hub that could be identified:

  • when the syringe was inspected before administration,
  • while the healthcare professional was securing the needle to the syringe,
  • during vaccine administration OR
  • during post-administration (e.g., when activating a safety needle)

The breakage resulted in a small number of injuries, including laceration and needle puncture.

Corrective Actions and Preventative Actions (CAPA) have been implemented at the syringe manufacturer to improve processes to help prevent these defects from recurring in future lots. MERCK is informing Health Care Providers of the glass breakage issue with the syringe and is providing guidance for handling and administration to further mitigate the risk of injury for the remaining material on the market until post-CAPA material is supplied.

Merck recommends that if you have VAXNEUVANCE™ from any of the recalled lots at your facility, you immediately quarantine and discontinue use of these doses and return the vaccine according to the procedure described in the attached documents. This product was distributed between November 16, 2022 through July 28, 2023. If you have further re-distributed this product, please identify those sites, and notify them immediately of this product recall.

For questions about this recall or to report any adverse events following vaccination, please contact:

  • Merck National Service Center: 800-672-6372 Select Prompt #1 then Prompt #2 (Monday to Friday 8:00 AM to 7:00 PM EST)

Merck will be notifying customers with business reply cards that will need to be filled out and returned with the recalled vaccines.

This voluntary recall is being conducted with the knowledge of the United States Food and Drug Administration (FDA).

Thank you for all you do.

Oakland County Health Division, Immunization Action Plan