Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428 58392 0 Product #282476; and b) Net Wt. 0.5 OZ tube (14.2 g) UPC 0 50428 31746 4 Product #896071; Distributed by CVS Pharmacy, Inc,. One CVS Drive, Woonsocket, RI 02895.
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 cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Reason Out of Specification for active ingredient
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
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