FDA-Drug2016-08-31Class III
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
Actavis Inc
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).
Sold states
Nationwide and Puerto Rico
Affected count
672 bottles
Manufactured in
400 Interpace Pkwy, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1471-2016Don't want to check this manually?
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