Actavis Inc recalls Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg…

Recall date

August 2, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1472-2016

FDA classification

Class III

Brand / firm

Actavis Inc

Sold / distributed

Nationwide and Puerto Rico

Why it was 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).

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61