Drug 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: 16.7% Mannitol, 3% Arginine, 1.5% Lysine, 0.9% Potassium Phosphate, 0.4% Methionine, 0.2% Edetate Disodium Dihydrate, 0.004% Sodium Metabisulfate, 0.0005% Polysorbate. Water for injection. Rx only, Olympia Pharmaceuticals NDC 73198-0082-00
D-0724-2022
Product summary
- Event
- Event 89717
- Status
- Terminated
- Classification
- Class II
- Quantity
- 836 vials
- Official record key
drug-enforcement:D-0724-2022
Official wording
Reason: Super Potent and Failed Reconstitution Time
Code information: Lot: D24001 Exp. 4/1/22
Distribution pattern: Nationwide in the USA including Puerto Rico.
Derived failure modes
-
Unknown
Super Potent and Failed Reconstitution Time