Hydromorphone HCL Syringes (Sentara Enterprises) – Sterility Concern (2015)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Sentara Enterprises
Lot Codes / Batch Numbers
d) 30-Sep-15, e) 30-Sep-15
Products Sold
All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 29-Sep-15 b) 30-Sep-15 c) 1-Oct-15, d) 30-Sep-15, e) 30-Sep-15
Sentara Enterprises is recalling HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125 due to Lack of Assurance of Sterility: Product sterility cannot be guaranteed.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NC, VA
Page updated: Jan 7, 2026