Sentara Recalls Dobutamine HCL Infusions Due to Sterility Concerns
Sentara Enterprises is recalling Dobutamine HCL in D5W home infusion bags 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection associated with non-sterile medical products.
Plain-English summary
Sentara Enterprises is recalling Dobutamine HCL in D5W, packaged as 240mg in 60ml and 1520mg in 380ml home infusion pumps. The recall affects 7 bags of the 60ml size and 4 bags of the 380ml size. These prescription-only products were compounded between September 11, 2015, and September 17, 2015, and were distributed in Virginia and North Carolina.
The recall was initiated because the sterility of the product cannot be guaranteed. This lack of assurance of sterility poses a potential risk to patients using the medication.
Patients and healthcare providers who have received these specific lots should contact their healthcare provider or Sentara Enterprises for further instructions on how to proceed.
The recalled product
- Product
- DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Infusion
- 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 (2)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15
- b) 25-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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