Sentara Recalls Clindamycin Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling 6 bags of Clindamycin 120mg in NS Homepumps because product 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as sterility assurance failures in injectable medications.
Plain-English summary
Sentara Enterprises is recalling 6 bags of CLINDAMYCIN 120MG in NS, packaged in 20ML Homepumps, which are prescription-only. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed.
The affected lots were compounded between September 11, 2015, and September 17, 2015, and have an expiration date of September 29, 2015. These products were distributed in the United States, specifically in Virginia and North Carolina.
Consumers and healthcare providers should stop using the affected products and contact their pharmacist or Sentara Home Health Sentara Rx for further instructions.
The recalled product
- Product
- CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Injectable
- Hazard
- Affected units
- 6
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: 29-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 failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereCMC Enterprise Pharmacy Recalls Clindamycin Bags Due to Sterility Concerns
FDA (Drugs) · 2019-05-01
- HighCaspofungin Injectable Medication Recalled for Sterility Assurance Issues
FDA (Drugs) · 2023-02-22
- HighVancomycin Injectable Bags Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighDaptomycin Antibiotic Injectable Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighVancomycin Intravenous Solution Recalled Due to Sterility Assurance Issue
FDA (Drugs) · 2023-02-22
- HighCefoxitin injectable bags recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-02-22