Recalls / Class II

Class IID-0724-2022

Product

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

Affected lot / code info

Lot: D24001 Exp. 4/1/22

Why it was recalled

Super Potent and Failed Reconstitution Time

Recalling firm

Firm

Olympia Compounding Pharmacy dba Olympia Pharmacy

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

6700 Conroy Rd Ste 155, N/A, Orlando, Florida 32835-3515

Distribution

Quantity

836 vials

Distribution pattern

Nationwide in the USA including Puerto Rico.

Timeline

Recall initiated

2022-03-08

FDA classified

2022-03-29

Posted by FDA

2022-03-30

Terminated

2023-10-04

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0724-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.