FDAFDA · Food and drugs·Recall number D-0724-2022
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
Published March 30, 2022 · Recall initiated: March 8, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Super Potent and Failed Reconstitution Time
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Distributor
- Nationwide in the USA including Puerto Rico.
- Lot
- Lot: D24001 Exp. 4/1/22
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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