Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
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 Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
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