FDAFDA · Food and drugs·Recall number D-1472-2016
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
Published August 31, 2016 · Recall initiated: August 2, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Actavis Inc
- Distributor
- Nationwide and Puerto Rico
- Lot
- L503092, Exp 04/2016
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States