PlainRecalls
FDA Drug Low Class III Terminated

Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.

Reported: March 28, 2018 Initiated: March 9, 2018 #D-0617-2018

Product Description

Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.

Reason for Recall

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Details

Recalling Firm
Akorn, Inc.
Units Affected
4,128 bottles
Distribution
Nationwide in the USA and Puerto Rico
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.. Recalled by Akorn, Inc.. Units affected: 4,128 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 28, 2018. Severity: Low. Recall number: D-0617-2018.