Microbiologics Inc recalls KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a…

Recall date

March 2, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0636-2022

FDA classification

Class III

Brand / firm

Microbiologics Inc

Sold / distributed

International distribution in the countries of Canada and Germany.

Why it was recalled

Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.