Drug 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
D-0949-2016
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 74099
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57,920 bottles
- Official record key
drug-enforcement:D-0949-2016
Official wording
Reason: Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Code information: Lot# 5A17A, Expiry 06/16 Lot# 5K21A, Expiry 03/17 Lot# 6A08A, Expiry 06/17
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility