PlainRecalls
FDA Drug Low Class III Terminated

Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.

Reported: August 31, 2016 Initiated: July 27, 2016 #D-1469-2016

Product Description

Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.

Reason for Recall

Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point

Details

Recalling Firm
Akorn, Inc.
Units Affected
4,045 units
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.. Recalled by Akorn, Inc.. Units affected: 4,045 units.
Why was this product recalled?
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Which agency issued this recall?
This recall was issued by the FDA Drug on August 31, 2016. Severity: Low. Recall number: D-1469-2016.