RecallRadar

FDA Drug recall D-0617-2018

Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062

On 2018-03-28 the FDA classified a Class III recall of Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062 by Akorn, citing failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0617-2018
ClassificationClass III
Statusterminated
Initiated2018-03-09
Published2018-03-28
Last updated2026-09-13 11:52 UTC
CompanyAkorn
DistributionUS

Product

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

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

Identifiers

code_infoLot# 2062900, Exp 05/18

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0617-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.