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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
See all 34 products in this recall →Related recalls
Same manufacturer · Sentara Enterprises
See all →- SevereSentara Recalls Nafcillin Bags Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-02-03
- HighSentara Recalls Sodium Chloride Homepumps Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Tobramycin Homepumps Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Intralipid Fat Emulsion Due to Sterility Assurance Issues
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Gentamicin Homepumps Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereBaptist Health Recalls Ascorbic Acid Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-06-08
- HighEthanol 70% Syringes Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighKYTRIL Antiemetic Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighNalbuphine Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighHydrocortisone Sterile Injection Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighInjectable Cefazolin-Heparin Syringes Recalled Nationwide for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22