Sentara Recalls Ascorbic Acid Syringes Due to Sterility Concerns
Sentara Enterprises is recalling 7 syringes of Ascorbic Acid 500mg because the product's 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are classified as Severe (Score 4).
Plain-English summary
Sentara Enterprises is recalling 7 syringes of Ascorbic Acid 500mg, packaged in 1ml syringes, due to a lack of assurance of sterility. The product is prescription-only and was distributed to Sentara Home Health Sentara RX in Chesapeake, Virginia, as well as in North Carolina.
The recall covers all lots compounded between September 11, 2015, and September 17, 2015, which had an expiration date of September 27, 2015. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers who have this specific product should stop using it and contact their healthcare provider or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Injectable
- Affected units
- 7
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 (1)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-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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