Summary
Stryker Corporation (SYK) has announced a voluntary recall of specific lots of Oral Care products from its Sage Products business unit due to a potential for cross-contamination. These products were manufactured by a third-party supplier between July 2015 and August 2017. While no serious adverse events have been reported, some instances of minor irritation and allergic reactions have occurred. Stryker has ceased using the affected third-party supplier and is now manufacturing the Oral Care solutions in-house, with a projected return to full supply capacity by year-end. Furthermore, the FDA has raised concerns regarding the microbiological testing methods used by Sage for all solution-containing products. This necessitates the adoption of a more time-consuming, verified compendial method for testing. Consequently, cloth-based products, representing a significant portion of Sage's revenue, have been temporarily placed on a ship hold pending this testing. Stryker anticipates resuming shipments of these products and returning to full supply capacity by the end of the year.
Key Highlights
- 1Voluntary recall of specific lots of Sage Oral Care products due to potential cross-contamination from a third-party supplier.
- 2No serious adverse events reported, but minor irritation and allergic reactions have been noted.
- 3Stryker has discontinued the relationship with the third-party supplier and is now manufacturing Oral Care solutions internally.
- 4FDA raised concerns about Sage's microbiological testing methods for all solution-based products.
- 5Cloth-based products (approx. 50% of Sage revenue) temporarily on hold pending testing with a new, compendial method.
- 6Stryker expects to resume shipping Oral Care products in September and all Sage products in September.
- 7Anticipates a return to full supply capacity for all affected Sage products by the end of the year.