CLASS II Drug recall · Reported 3 Feb 2016 · FDA Enforcement Report
Solu-Cortef (hydrocortisone) 1MG in NS recalled by Sentara Enterprises
Sentara Enterprises is recalling Solu-Cortef (hydrocortisone) 1MG in NS, distributed in North Carolina, Virginia. The recall was initiated on 18 Sep 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0640-2016
- FDA event ID
- 72746
- Recalling firm
- Sentara Enterprises, Chesapeake, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Sep 2015
- FDA classified
- 28 Jan 2016
- Reported
- 3 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 18 Sep 2015 | Recall initiated by company | |
| 28 Jan 2016 | Classified by FDA | +132 days |
| 3 Feb 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it was distributed
U.S. Including: VA, NC
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Which lots are affected?
All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 28-Sep-15, 30-Sep-15
Where was it sold?
U.S. Including: VA, NC
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
33 other products · FDA event 72746This product is part of a recall event; the main page for the event is Dextrose-NaCl (D5-1/2NS) in NS recalled by Sentara Enterprises.
More recalls from Sentara Enterprises
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Morphine 10MG/ML in NS recalled by Sentara Enterprises | Sentara Enterprises | Sterility | NC, VA |
| Drug | CLASS II | Ceftriaxone in NS, Packaged as a) 1GM in Homepumps recalled | Sentara Enterprises | Sterility | NC, VA |
| Drug | CLASS II | Cubicin (daptomycin) in NS, Packaged as a) 350MG recalled | Sentara Enterprises | Sterility | NC, VA |
| Drug | CLASS II | Fluconazole IN Nacl 400MG in NS recalled by Sentara Enterprises | Sentara Enterprises | Sterility | NC, VA |
| Drug | CLASS II | Potassium Chloride in D 5 1/2NS recalled by Sentara Enterprises | Sentara Enterprises | Sterility | NC, VA |