Olympia Compounding Pharmacy dba Olympia Pharmacy: Drug Recall

Recall #D-0724-2022 · 03/08/2022

Class II: Risk

Recall Details

Recall Number: D-0724-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Olympia Compounding Pharmacy dba Olympia Pharmacy
Status: Terminated
Date Initiated: 03/08/2022
Location: Orlando, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 836 vials

Reason for Recall

Super Potent and Failed Reconstitution Time

Product 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

Distribution Pattern

Nationwide in the USA including Puerto Rico.

Other Recalls by Olympia Compounding Pharmacy dba Olympia Pharmacy

Class II: Risk 05/09/2022

Lack of assurance of sterility.
Class II: Risk 05/09/2022

Lack of assurance of sterility.
Class II: Risk 05/09/2022

Lack of assurance of sterility.
Class II: Risk 05/09/2022

Lack of assurance of sterility.
Class II: Risk 05/09/2022

Lack of assurance of sterility.

View all recalls by Olympia Compounding Pharmacy dba Olympia Pharmacy →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.