Rocuronium Bromide Syringes Recalled for Sterility Assurance Issue
Denver Solutions recalls 16,655 Rocuronium Bromide syringes nationwide due to damaged or leaking units that compromise sterility assurance. Lot #2530023 expires 7/12/2025.
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 with no reported illnesses or injuries. The hazard—lack of sterility assurance in injectable medication due to leaking or damaged syringes—represents a risk of harm (infection) but is theoretical at this time. Per the rubric, risk-of-harm products with no reported injury score as High (3).
Plain-English summary
Rocuronium Bromide is an injectable muscle relaxant used during anesthesia. Denver Solutions, LLC DBA Leiters Health, is recalling 16,655 single-dose syringes of Rocuronium Bromide (50 mg per 5mL, 10mg/mL) due to lack of assurance of sterility caused by leaking or damaged syringes.
The recalled product was distributed nationwide in the United States. Affected syringes carry Lot #2530023 with an expiration date of 7/12/2025.
When syringe integrity is compromised by leaking or damage, sterility of the medication cannot be assured, which could result in contamination or infection upon injection. No illnesses have been reported to date. Patients who received syringes from this lot should contact their healthcare provider immediately. Healthcare facilities should quarantine affected inventory and inspect all units for signs of leaking or damage before use.
The recalled product
- Product
- Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug — Injectable
- Hazard
- sterility-compromise
- infection-risk
- product-integrity
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 #:2530023
- Exp.: 7/12/2025
Distribution
Distributed nationwide across the United States.
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