HYDROmorphone Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center recalled 22,805 pre-filled syringes of HYDROmorphone HCl Injection due to lack of sterility assurance. Six lot numbers were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of injectable medication where sterility cannot be assured. No illnesses or injuries have been reported. The hazard is theoretical contamination risk rather than confirmed harm. Per the rubric, a risk-of-harm product without reported injury scores 3 (High).
Plain-English summary
Nephron Sterile Compounding Center LLC has recalled HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) pre-filled syringes. The recall affects approximately 22,805 syringes across six lot numbers: HH2002A (expires 7/7/2022), HH2004A (expires 8/28/2022), HH2005A (expires 8/11/2022), HH2007A (expires 9/2/2022), HH2009A (expires 9/10/2022), and HH2011A (expires 10/17/2022).
The manufacturer cannot assure that the affected product is sterile. Use of non-sterile injectable medication poses a risk of microbial contamination and potential infection in patients receiving injections.
The recalled product was distributed nationwide in the United States. Product from the affected lot numbers should not be administered to patients.
The recalled product
- Product
- HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable Opioid
- Affected units
- 22,805
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 (12)
- Lots: HH2002A
- Exp. 7/7/2022
- HH2004A
- Exp. 8/28/2022
- HH2005A
- Exp. 8/11/2022
- HH2007A
- Exp. 9/2/2022
- HH2009A
- Exp. 9/10/2022
- HH2011A
- Exp. 10/17/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 37 recalled by Nephron Sterile Compounding Center LLC 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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