D-0949-2016 Class II Terminated
FDA drug recall D-0949-2016 was initiated by Akorn, Inc. on May 17, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability The recall status is terminated (terminated Jul 21, 2017). Affected quantity: 57,920 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 8, 2016
- Initiation Date
- May 17, 2016
- Termination Date
- Jul 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57,920 bottles
Product Description
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
Reason for Recall
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
Lot# 5A17A, Expiry 06/16 Lot# 5K21A, Expiry 03/17 Lot# 6A08A, Expiry 06/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0949-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026