Sincalide Powder (Olympia Pharmacy) – Potency Issues (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Olympia Compounding Pharmacy dba Olympia Pharmacy
Lot Codes / Batch Numbers
Lot: D24001 Exp. 4/1/22
Products Sold
Lot: D24001 Exp. 4/1/22
Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lys due to Super Potent and Failed Reconstitution Time. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Super Potent and Failed Reconstitution Time
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026