The Recall Desk
SevereFDA (Drugs)·D-0631-2016·Announced 2016-02-03

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
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

Distributed in 2 states:

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 →