Recalls / Class II
Class IID-0949-2016
Product
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
- Affected lot / code info
- Lot# 5A17A, Expiry 06/16 Lot# 5K21A, Expiry 03/17 Lot# 6A08A, Expiry 06/17
Why it was recalled
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 57,920 bottles
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2016-05-17
- FDA classified
- 2016-05-29
- Posted by FDA
- 2016-06-08
- Terminated
- 2017-07-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0949-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.