Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Q.Care Oral Cleansing & Suctioning System q8. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 1 Suction Oral Swab packages with Perox-A-Mint solution, 1 Oropharyngeal Suction Catheter package. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6808 UPC 6 18029 84122 3
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Reason Failed Impurities/Degradation Specifications
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
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