Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL pharmacy II, 4909 W Park Blvd, Suite 177, Plano, TX 75093 --- NDC 88888-0043-31
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: Out of specification results for micro in hand soap products.
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Reason Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Reason Microbial contamination
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
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