HYDROmorphone HCl Injection Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center is recalling HYDROmorphone HCl Injection syringes nationwide due to lack of assurance of sterility. The recall affects 12,900 syringes across two manufacturing lots.
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 drug recall for a sterile injectable product with lack of sterility assurance. No illnesses or injuries have been reported. The score of 3 reflects that this is a risk-of-harm product where injury has not yet been reported, per the severity rubric.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) pre-filled syringes nationwide in the United States. The recalled product consists of 12,900 syringes from two manufacturing lots: HH2003A (expiring 7/26/2022) and HH2006A (expiring 8/22/2022).
The recall was issued due to lack of assurance of sterility. Sterility is a critical quality requirement for injectable medications. The manufacturer was unable to confirm that the product met required sterility standards.
This product was distributed nationwide. Patients and healthcare providers with access to these syringes should not use them. Anyone who may have used this product should contact their healthcare provider for guidance.
The recalled product
- Product
- HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 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: 69374-529-30
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable Medication
- Hazard
- lack-of-sterility-assurance
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 (4)
- Lots: HH2003A
- Exp. 7/26/2022
- HH2006A
- Exp. 8/22/2022
Distribution
Distributed nationwide across the United States.
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