Actavis Hydrocortisone and acetic acid otic solution Recall

Why it was 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).

Product description

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

Lot numbers, UPCs & expiration codes

L503092, Exp 04/2016

Where it was sold

Nationwide and Puerto Rico

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1472-2016
Classification: Class III
Status: Terminated
Recall initiated: Aug 2, 2016
FDA report date: Aug 31, 2016
Quantity: 2543 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Actavis Inc

Original FDA data

Every field from FDA enforcement report D-1472-2016, exactly as published.

Show all FDA fields

City: Parsippany
State: NJ
Status: Terminated
Country: United States
Event ID: 74902
Address: 400 Interpace Pkwy
Code information: L503092, Exp 04/2016
Postal code: 07054-1120
Report date: Aug 31, 2016
Product type: Drugs
Recall number: D-1472-2016
Classification: Class III
Recalling firm: Actavis Inc
Product quantity: 2543 bottles
Termination date: Feb 8, 2017
Reason for recall: 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).
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide and Puerto Rico
Recall initiation date: Aug 2, 2016
Initial firm notification: Letter
Center classification date: Aug 24, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1472-2016, published Aug 31, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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