Hydrocortisone and acetic acid otic solution — Class III drug recall D-1472-2016
Terminated recall by Actavis Inc, reported 2016-08-31, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were o
| Recall number | D-1472-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Inc, Parsippany, NJ, United States |
| Recall initiated | 2016-08-02 |
| Classified | 2016-08-24 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2017-02-08 |
| Distributed | Nationwide (US) |
| Quantity | 2,543 bottles |
| Reason classes | specification failure |
| NDC | 45963-0412-61 |
| Expiration dates | 2016-04 |
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
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1472-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.