Product Safety Recalls

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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

Mandated?Voluntary: Firm initiated
Recall NumberD-0724-2022
Event ID89717
DistributionNationwide in the USA including Puerto Rico.
Quantity836 vials
Recall ReasonSuper Potent and Failed Reconstitution Time
Drug ClassificationClass II
Drug Code Info20220330
Recall Initiation Date20220308
Report Date20220330
Classification Date20220329
Address6700 Conroy Rd Ste 155
Orlando, FL 32835-3515
United States
Recalling FirmOlympia Compounding Pharmacy dba Olympia Pharmacy
Initial Notification Letter
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