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BRIEF-Stryker provides update regarding Sage warning letter
August 23, 2017 / 12:22 PM / 4 months ago

BRIEF-Stryker provides update regarding Sage warning letter

Aug 23 (Reuters) - Stryker Corp:

* Reg-Stryker provides an update regarding sage warning letter and revised financial guidance

* Stryker Corp says informed U.S. FDA of voluntary product recall involving specific lots of oral care products sold through sage products business unit​

* Stryker - ‍recalled products contain oral care solutions manufactured for sage by third-party supplier,were distributed between July 2015 and Aug 2017​

* Recall is being initiated due to a potential for cross-contamination of oral care solutions

* Says ‍to date, stryker has not been made aware of any serious adverse events associated with oral care products recall​

* Stryker - ‍has discontinued business with third-party supplier and all oral care solutions are being manufactured in-house by Sage​

* Stryker says anticipates that adjusted net earnings per diluted share will be at lower end of its previously stated range of $1.50-$1.55 for q3​

* Stryker - ‍expects to resume shipping oral care products in September and anticipates a return to full supply capacity by year end​

* Says ‍there have been some reports of minor irritation and allergic reaction related to the products​

* Stryker - FDA warning letter sets forth concerns regarding microbiological testing methods used for all products containing solutions sold by sage

* Says ‍anticipates it will resume shipping products manufactured by sage and tested under compendial method in September​

* Stryker - expects full year organic sales growth and adjusted net earnings per diluted share to be at lower end of its previously stated range

* Q3 earnings per share view $1.53 -- Thomson Reuters I/B/E/S Source text for Eikon: Further company coverage:

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