Sentara Recalls Hydromorphone HCL Due to Sterility Assurance Concerns
Sentara Enterprises is recalling specific lots of Hydromorphone HCL 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 severity score under the rubric for potential serious adverse health consequences.
Plain-English summary
Sentara Enterprises is recalling specific lots of Hydromorphone HCL, a prescription-only medication. The product is packaged in various forms, including 2.5mg in 1ml syringes and multiple concentrations in 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. The recall covers 42 syringes and 15 homepump bags distributed in Virginia and North Carolina. The expiration dates for the affected products range from September 29, 2015, to October 1, 2015.
Consumers and healthcare providers should stop using the affected Hydromorphone HCL products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e) 135MG in 135ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Injectable Medication
- 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)
- d) 30-Sep-15
- e) 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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