Actavis Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities
Actavis Inc. is recalling 2,543 bottles of Hydrocortisone and acetic acid otic solution because stability testing showed out-of-specification results for a related compound.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a stability specification failure without reported injuries or illnesses.
Plain-English summary
Actavis Inc. is recalling 2,543 bottles of Hydrocortisone and acetic acid otic solution, a prescription-only medication distributed in 10 mL bottles. The affected product is identified by NDC 45963-412-61, lot number L503092, and an expiration date of 04/2016.
The recall was initiated because stability testing at the 12-month time point for room temperature samples resulted in out-of-specification (OOS) findings for related compound G. This indicates a failure to meet impurities and degradation specifications.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Actavis Inc
- Category
- Drug — Otic Solution
- Hazard
- Affected units
- 2,543
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- L503092
- Exp 04/2016
Distribution
Part of a larger recall action
This product is one of 2 recalled by Actavis Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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