Sulfacetamide Sodium Ophthalmic Solution recall: Sterility Concern
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
Why was Sulfacetamide Sodium Ophthalmic Solution recalled?
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# 5A17A, Expiry 06/16 Lot# 5K21A, Expiry 03/17 Lot# 6A08A, Expiry 06/17
- 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
- Recalling firm
- Akorn, Inc.
- Quantity
- 57,920 bottles
- Distribution
- Nationwide and Puerto Rico.
- Recall date
- June 8, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)