Reported Jun 8, 2016 · Terminated
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest,…
Akorn, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
- Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd
- byAkorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
- Lot codes and dates
Lot# 5A17AExpiry 06/16 Lot# 5K21AExpiry 03/17 Lot# 6A08AExpiry 06/17
- Amount recalled
- 57,920 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
This product could cause temporary or reversible health problems — stop using it.
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