Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183
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 Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
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