Actavis Inc recalls Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatla

Recalled August 31, 2016 · FDA recall D-1471-2016 · Actavis

Hazard

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). · FDA Class III

Units

672 bottles

Sold at

Nationwide and Puerto Rico

Description

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).

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(s)

Actavis Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →