D-0724-2022 Class II Terminated
FDA drug recall D-0724-2022 was initiated by Olympia Compounding Pharmacy Dba Olympia Pharmacy on Mar 8, 2022 and is designated Class II. Reason for recall: Super Potent and Failed Reconstitution Time The recall status is terminated (terminated Oct 4, 2023). Affected quantity: 836 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 30, 2022
- Initiation Date
- Mar 8, 2022
- Termination Date
- Oct 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 836 vials
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
Reason for Recall
Super Potent and Failed Reconstitution Time
Distribution Pattern
Nationwide in the USA including Puerto Rico.
Code Information
Lot: D24001 Exp. 4/1/22
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0724-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026