The Recall Desk
HighFDA (Drugs)·D-0374-2025·Announced 2025-04-30

[pending] Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 1

Pending LLM rewrite. Source: FDA_DRUG D-0374-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

Lack of Assurance of Sterility: Leaking/damaged syringes.

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

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.