Sentara Recalls Solu-Cortef Syringes Due to Sterility Concerns
Sentara Enterprises is recalling 9 bags of Solu-Cortef (hydrocortisone) 1MG in NS syringes because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility failure in injectable drugs) are categorized as Severe (Score 4), especially given the risk of infection from non-sterile injectables.
Plain-English summary
Sentara Enterprises is recalling 9 bags of Solu-Cortef (hydrocortisone) 1MG in NS, packaged in 0.1ML syringes, due to a lack of assurance of sterility. The FDA has classified this as a Class II recall, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The affected product was compounded between September 11, 2015, and September 17, 2015, with expiration dates of September 28, 2015, and September 30, 2015. The recall covers distribution in the United States, specifically including the states of Virginia and North Carolina.
Consumers and healthcare providers should check their inventory for these specific lots and discontinue use if found. Patients who have received this medication should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- 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.
- Manufacturer
- Sentara Enterprises
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 28-Sep-15
- 30-Sep-15
Distribution
Part of a larger recall action
This product is one of 34 recalled by Sentara Enterprises under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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