# FDA recall D-1471-2016

> **Actavis Inc** · Class III · drug recall initiated 2016-08-02.

## 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

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1471-2016
- **Recalling firm:** Actavis Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-02
- **Report date:** 2016-08-31
- **Termination date:** 2017-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1471-2016

## Citation

> AI Analytics. FDA recall D-1471-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1471-2016. Source: US FDA. Licensed CC0.

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