Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00009-0011-04
Affected NDC
0009-0011-04
Compare with the code on your package — it is the most precise check available.
Drug: Hydrocortisone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Solu-Cortef hydrocortisone sodium succinate NDC 00009-0011 |
100 mg/2mL | Injection, Powder, for Solution Intramuscular|intravenous |
Pharmacia & Upjohn Company LLC | Rx |
- Recalling firm
- Sentara Infusion Services
- NDC code
- 00009-0011-04
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0295-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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