FDAMarch 31, 2025drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of Assurance of Sterility: Leaking/damaged syringes.

What to do

FDA enforcement status: Ongoing

Brands named

denver solutions llc dba leiters healthdenverdenver solutions

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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