Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Hydrocortisone and acetic acid otic solution Recalled by Actavis Inc Due to Failed Impurities/Degradation Specifications: Out of specification (OOS) results...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Actavis Inc directly.
Affected 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
Quantity: 2543 bottles
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Actavis Inc
Actavis Inc has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report