NDC 50383-901
hydrocortisone and acetic acid 20.75 mg per 1 mL / 10.375 mg per 1 mL solution
On the label: Akorn.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Akorn | Location not on file | Makes it | Not inspected on record |
Recalls
- Dec 16, 2019 · Class II · Akorn Inc
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Lots: Lot #: 364667, Exp 12/20/2019 - Mar 12, 2019 · Class II · Akorn Inc
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Lots: Lot: 357647, EXP 04/2019 - Aug 21, 2015 · Class III · Akorn, Inc.
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
Lots: Lot # 346191, Exp. 12/2016
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
- Strength
- 20.75 mg per 1 mL / 10.375 mg per 1 mL
- Approval
- NDA NDA012770
- On the market since
- Jun 4, 2009
- Package NDCs
50383-901-10- Official label
- DailyMed (National Library of Medicine), updated Oct 13, 2022
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