Sentara Recalls Penicillin in D5W Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Penicillin in D5W Homepumps because the sterility of the product cannot be guaranteed.
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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are mapped to a score of 4 (Severe), particularly when involving significant risks such as sterility assurance failures in injectable medications.
Plain-English summary
Sentara Enterprises is recalling specific lots of Penicillin in D5W, packaged in Homepumps, due to a lack of assurance of sterility. The affected products are prescription-only and were compounded between September 11, 2015, and September 17, 2015. The recall includes two packaging configurations: 36MU in 360ML Homepumps and 51MU in 510ML Homepumps.
The recall is limited to products with expiration dates of September 27, 2015, September 28, 2015, or September 30, 2015. These products were distributed in the United States, specifically in Virginia and North Carolina. The recall was initiated because the manufacturer cannot guarantee that the product is sterile.
Patients who have received these specific lots of medication should contact their healthcare provider or Sentara Home Health for further instructions. The FDA classifies this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Antibiotic
- Hazard
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 (3)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 27-Sep-15
- b) 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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