Class III · Low risk Terminated
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Reason Subpotent drug
Sulfacetamide Sodium Ophthalmic Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
What was recalled
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
- Recalling firm
- Akorn, Inc.
- NDC code
- 17478-221-12
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0949-2016
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 Sulfacetamide recalls
See all
Class III · Low risk Terminated
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Reason Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class II · Moderate risk Terminated
CSF-HC Otic Insufflation Capsule
Reason CGMP Deviations
Class II · Moderate risk Terminated
CSF Otic Insufflation Capsule
Reason CGMP Deviations
Class III · Low risk Terminated
Sodium Sulfacetamide
Reason Subpotency: one product for active ingredient assay and another one for preservative assay
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