Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT…
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
6 FDA recalls mention Esmolol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Esmolol.
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Reason Lack of Assurance of Sterility
Reason Lack of sterility assurance.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Discoloration: presence of atypical yellow discoloration of the solution .
Reason Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
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