Class II · Moderate risk Ongoing
Compliance Dishwashing Liquid & Antibacterial Soap
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Cortisol-Mc
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
What was recalled
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
- Recalling firm
- Abrams Royal Pharmacy II, LLC
- NDC code
- 88888-0043-31
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1231-2015
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.
Other Royal recalls
See all
Class II · Moderate risk Ongoing
ROYALAB Germ Away Antibacterial Hand Soap
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Terminated
DermOtic Oil
Reason Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class I · High risk Terminated
NET Remedies #8
Reason Microbial contamination
Class III · Low risk Terminated
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01%
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
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