FDA Recalls HYDROmorphone Injection Syringes Due to Sterility Concerns
Nephron Sterile Compounding Center is recalling 3,740 HYDROmorphone injection syringes due to lack of assurance of sterility. The affected lot was 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 a Class II FDA recall of a sterile injectable product where no illnesses or injuries have been reported. Per the severity rubric, 'risk-of-harm products where injury has not yet been reported' are classified as High. While lack of sterility assurance poses a theoretical risk of serious infection, the absence of reported harm places this in the High category.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) pre-filled syringes due to lack of assurance of sterility. Approximately 3,740 syringes of lot HN2002A with an expiration date of July 26, 2022 have been distributed nationwide in the United States.
The product is supplied as 5 pre-filled syringes per carton, distributed in cases of 6 cartons. The manufacturer is Nephron Sterile Compounding Center LLC, a 503B outsourcing facility located at 4500 12th St. Extension, West Columbia, South Carolina. The recalled product is identified by NDC 69374-559-50.
The recalled product
- Product
- HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable Opioid
- Hazard
- lack-of-sterility
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)
- Lot: HN2002A
- Exp. 7/26/2022
Distribution
Distributed nationwide across the United States.
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