Class II
Terminated
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
- Company
- Akorn, Inc.
- Recall Initiated
- May 17, 2016
- Posted
- June 8, 2016
- Recall Number
- D-0949-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 57,920 bottles
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Distribution
Nationwide and Puerto Rico.
Lot / Code Info
Lot# 5A17A, Expiry 06/16 Lot# 5K21A, Expiry 03/17 Lot# 6A08A, Expiry 06/17
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