Class II · Moderate risk Terminated
Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0556-15
Reason cGMP deviations: Temperature abuse
Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Recalling firm
- KRS Global Biotechnology, Inc
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0197-2018
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.
Other Sincalide recalls
See all
Class II · Moderate risk Terminated
Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd…
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly…
Class II · Moderate risk Terminated
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate…
Reason Super Potent and Failed Reconstitution Time
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