Hydromorphone Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection 50 mg/50 mL pre-filled syringes due to lack of sterility assurance. The recalled product was distributed nationwide.
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 3/5 (High).
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: FDA Class II classification with no reported illnesses or injuries. The hazard is theoretical lack of sterility assurance. Per the rubric, risk-of-harm products without reported injury score at most 3 (High).
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) supplied in 50 mL pre-filled syringes. The recalled product consists of 2,795 syringes with lot number HN2005A and an expiration date of 9/17/2022, with NDC 69374-559-50.
The product is being recalled due to lack of assurance of sterility.
The recalled syringes were distributed nationwide in the United States. Patients currently using this medication or healthcare facilities with this product in inventory should contact their healthcare provider or pharmacist for guidance. Do not use the affected syringes.
The recalled product
- Product
- Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, 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
- Hazard
- Affected units
- 2,795
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: HN2005A
- Exp. 9/17/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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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