Class II · Moderate risk Ongoing
Compliance Dishwashing Liquid & Antibacterial Soap
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
All Unexpired Sterile Drug Products
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
- Recalling firm
- Abrams Royal Pharamacy
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1564-2014
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
Cortisol-Mc
Reason Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
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