FDA Drug recall 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 07…
- FDA Drug
- Class III
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class III recall of Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07… by Actavis, citing 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 tempera….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1472-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-08-02 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis |
| Distribution | US |
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
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).
Identifiers
| code_info | L503092, Exp 04/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1472-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.