Rocuronium Bromide Syringes Recalled Due to Sterility Assurance Risk
Denver Solutions, LLC DBA Leiters Health is recalling Rocuronium Bromide 50 mg per 5mL syringes due to potential leaking or damage that may compromise sterility assurance.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterility assurance failure in an injectable drug. Loss of sterility in parenteral medications creates a significant risk of serious adverse outcomes including infection; the source text identifies lack of sterility assurance as the hazard, which meets the Severe criterion for injectable products with potential for serious harm.
Plain-English summary
Rocuronium Bromide 50 mg per 5mL single-dose syringes (10 mg per mL), distributed nationwide in the U.S., are being recalled by Denver Solutions, LLC DBA Leiters Health due to lack of assurance of sterility caused by leaking or damaged syringes. The affected product is NDC 71449-004-11, Lot #2530023, with an expiration date of 7/12/2025. Approximately 16,655 syringes have been distributed.
Leaking or damaged syringes may compromise the sterile integrity of the medication. Rocuronium Bromide is an injectable drug used in medical settings, and compromised sterility poses a risk of contamination.
Patients and healthcare providers in possession of affected syringes should cease use immediately. Contact Denver Solutions, LLC DBA Leiters Health or consult your healthcare provider for guidance on affected product handling and replacement.
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 / Parenteral
- Affected units
- 16,655
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.
Part of a larger recall action
This product is one of 5 recalled by Denver Solutions, LLC DBA Leiters Health 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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