The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0617-2018·Announced 2018-03-28

Akorn Recalls Triamcinolone Acetonide Lotion Due to Impurity Levels

Akorn, Inc. is recalling 4,128 bottles of Triamcinolone Acetonide Lotion, USP 0.1% due to high impurity levels. The product was distributed nationwide and in Puerto Rico.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Akorn, Inc. is recalling 4,128 bottles of Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only. The product is marketed by VersaPharm Incorporated and manufactured by Ei LLC. The specific lot number is 2062900 with an expiration date of 05/18.

The recall was initiated because the product failed impurities/degradation specifications, specifically showing high out-of-specification results for an impurity. The FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.

The affected product was distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should check their inventory for this specific lot and expiration date. If found, the product should be returned to the pharmacy or distributor for disposal or credit.

The recalled product

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.
Manufacturer
Akorn, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
4,128

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot# 2062900
  • Exp 05/18

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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