Product: Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compounding Pharmacy Compounded by: Olympia Pharmacy Conroy Rd., Ste. 155, Orlando, FL 32835, NDC 73198-0082-00   Revised Label: Sincalide Lyophilized powder for reconstitution, 5mcg per multi dose vial,  Each ML contains: 16.
Reason for recall: Super Potent and Failed Reconstitution Time
Recall initiated: 20220308
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated