Piramal Critical Care, Inc. is recalling approximately 100 glass vials of Rocuronium Bromide Injection (50mg/5 mL). The recall was initiated because the vials were missing a critical statement on the flip cap warning that the medication is a paralyzing agent. This medication is used in hospitals and clinics for patients undergoing surgery or requiring mechanical ventilation. No incidents or injuries have been reported to date.
The absence of the paralyzing agent warning on the vial cap could lead to accidental administration of the drug to patients who do not require it. Because this drug paralyzes the muscles used for breathing, accidental administration can cause respiratory arrest, serious injury, or death if not immediately managed by medical staff.
Quarantine and return
Recall #: D-0019-2022. Quantity: 100 glass vials. Labeling error: Flip cap lacks 'WARNING: PARALYZING AGENT'.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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