Actavis Inc recalls Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B
Recalled August 31, 2016 · FDA recall D-1472-2016 · 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
2543 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
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
Manufacturer(s)
Actavis Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →