Recall D-0724-2022
Description: 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
Recall D-0724-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0724-2022 |
| Event ID | 89717 |
| Distribution | Nationwide in the USA including Puerto Rico. |
| Quantity | 836 vials |
| Recall Reason | Super Potent and Failed Reconstitution Time |
| Drug Classification | Class II |
| Drug Code Info | 20220330 |
| Recall Initiation Date | 20220308 |
| Report Date | 20220330 |
| Classification Date | 20220329 |
| Address | 6700 Conroy Rd Ste 155 Orlando, FL 32835-3515 United States |
| Recalling Firm | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Initial Notification | Letter |
| Similar To |