FDA-Drug2016-08-31Class III
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
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
2543 bottles
Manufactured in
400 Interpace Pkwy, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1472-2016Don't want to check this manually?
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