Drug recall
KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized…
FDA recall event 89412 · Class III · Microbiologics Inc
Key facts
| Event ID | 89412 |
|---|---|
| Recall numbers | Z-0636-2022, Z-0637-2022 |
| Recalling firm | Microbiologics Inc |
| Product type | Devices |
| Products | 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…, LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. |
| Initiation date | Mar 2, 2017 |
| Report date | Feb 16, 2022 |
| Termination date | Apr 22, 2022 |
| City | Saint Cloud |
| State | MN |
| Country | United States |
| FEI number | 2150138 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: