FDA recall D-0949-2016

Akorn, Inc. · Class II · 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

Reason for recall

Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability

Distribution

Nationwide and Puerto Rico.

Key facts

Status
Terminated
Initiation date
2016-05-17
Report date
2016-06-08
Termination date
2017-07-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0949-2016