Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
Reported: June 8, 2016 Initiated: May 17, 2016 #D-0949-2016
Product Description
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
Reason for Recall
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 57,920 bottles
- Distribution
- Nationwide and Puerto Rico.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product 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. Recalled by Akorn, Inc.. Units affected: 57,920 bottles.
Why was this product recalled? ▼
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 8, 2016. Severity: Moderate. Recall number: D-0949-2016.
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