Sentara Recalls Morphine Infusion Bags Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Morphine 10mg/ml in NS 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 for potential serious, reversible health consequences.
Plain-English summary
Sentara Enterprises is recalling 5 bags of 150ml and 4 bags of 250ml of Morphine 10mg/ml in NS, packaged in Homepumps. The affected product was compounded between September 11, 2015, and September 17, 2015, and was distributed in Virginia and North Carolina. The recall is being conducted because the company cannot guarantee the sterility of the product.
Patients who have received these specific infusion bags should contact their healthcare provider for further instructions. The recall is limited to the specific lots and expiration dates identified in the recall notice.
The recalled product
- Product
- MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Infusion Solution
- 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) 25-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.
See all 34 products in this recall →Related recalls
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