The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1471-2016·Announced 2016-08-31

Actavis Recalls Acetasol HC Otic Solution Due to Impurity Failure

Actavis Inc is recalling 672 bottles of Acetasol HC otic solution because stability testing showed an out-of-specification related compound at the 12-month time point.

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 unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2.

Plain-English summary

Actavis Inc is recalling 672 bottles of Acetasol HC (hydrocortisone and acetic acid otic solution USP), a prescription-only medication in 10 mL bottles. The product is identified by NDC 0472-0882-82, lot number L503092, and an expiration date of 04/2016. The recall was initiated because out-of-specification results for related compound G were obtained at the 12-month stability time point for room temperature samples.

The recalled product was distributed nationwide and in Puerto Rico. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or disposal. The recall is limited to the specific lot and expiration date listed above.

The recalled product

Product
Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
Manufacturer
Actavis Inc
Category
Drug — Otic Solution
Hazard
Affected units
672

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)

  • L503092
  • Exp 04/2016

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Actavis Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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