NDC 51672-3007
Hydrocortisone and Acetic Acid 10.4 mg per 1 mL / 20.8 mg per 1 mL solution
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharma Canada Inc. | Brampton, Canada | Makes it | No problems foundMar 27, 2026 · 7 inspections |
Recalls
- Aug 7, 2024 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Lots: Lot # AD12890, Exp 09/30/2024 - Nov 6, 2023 · Class III · Taro Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Lots: Lot# AC86809, AC86812, Exp Date: 01/31/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Acetic Acid and Hydrocortisone: every company that makes it
- Form
- solution, auricular (otic)
- Strength
- 10.4 mg per 1 mL / 20.8 mg per 1 mL
- Approval
- ANDA ANDA088759
- On the market since
- Apr 28, 2005
- Package NDCs
51672-3007-1- Official label
- DailyMed (National Library of Medicine), updated Jul 7, 2025
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