Sentara Recalls Gentamicin Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Gentamicin Homepumps because the sterility of the product cannot be guaranteed. The affected bags were 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, and the rubric specifies that FDA Class II recalls involving hospitalization reports or significant injury/property damage are Severe. While no injuries are explicitly reported in the text, the lack of sterility assurance for an injectable antibiotic is a significant risk factor that aligns with the Severe classification for Class II drug recalls.
Plain-English summary
Sentara Enterprises is recalling specific lots of Gentamicin, packaged in 70mg/70ml, 80mg/80ml, and 375mg/75ml Homepumps. The recall is being conducted because the company cannot guarantee the sterility of the product. The affected lots were compounded between September 11, 2015, and September 17, 2015, and have expiration dates ranging from September 24, 2015, to September 30, 2015.
The recall involves 11 bags of the 70mg/70ml formulation, 9 bags of the 80mg/80ml formulation, and 3 bags of the 375mg/75ml formulation. These prescription-only products were distributed in the United States, specifically in Virginia and North Carolina.
Patients who have received these specific bags of Gentamicin should contact their healthcare provider or Sentara Home Health for further instructions on how to proceed.
The recalled product
- Product
- GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Antibiotic
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) 30-Sep-15
- b) 25-Sep-15
- c) 24-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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