Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviations: Temperature abuse
Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0556-15
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly…
Reason Super Potent and Failed Reconstitution Time
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
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