Sentara Recalls Potassium Chloride Infusions Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Potassium Chloride in D 5 1/2NS home infusion bags because sterility 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or hospitalization.
Plain-English summary
Sentara Enterprises is recalling specific lots of Potassium Chloride in D 5 1/2NS, packaged in 1000 mL and 500 mL home infusion bags. The recall is being conducted because the sterility of the product cannot be guaranteed.
The affected products are prescription-only home infusion bags distributed in Virginia and North Carolina. The recall covers all lots compounded between September 11, 2015, and September 17, 2015, which have an expiration date of September 30, 2015.
Consumers and healthcare providers should stop using the affected products immediately and contact their healthcare provider or Sentara Enterprises for further instructions.
The recalled product
- Product
- POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Infusion Solution
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 (2)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15
- b) 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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