PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: August 31, 2016 Initiated: August 2, 2016 #D-1471-2016

Product Description

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).

Details

Recalling Firm
Actavis Inc
Units Affected
672 bottles
Distribution
Nationwide and Puerto Rico
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Actavis Inc. Units affected: 672 bottles.
Why was this product recalled?
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).
Which agency issued this recall?
This recall was issued by the FDA Drug on August 31, 2016. Severity: Low. Recall number: D-1471-2016.