Sincalide Injectable Vials Recalled for Manufacturing Monitoring Failures
Olympia Compounding Pharmacy is recalling 1,770 vials of Sincalide due to CGMP deviations in environmental and personnel monitoring. The manufacturer failed to properly investigate monitoring excursions prior to October 2021.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall due to CGMP monitoring deviations with no reported illnesses, hospitalizations, or confirmed contamination. This is a precautionary manufacturing quality control failure without evidence of patient harm.
Plain-English summary
Olympia Compounding Pharmacy is recalling 1,770 vials of Sincalide, 5 mcg lyophilized powder for reconstitution (NDC 73198-0082-00), distributed nationwide in the United States. The recall applies to two product lots: F24018 (best-use date June 18, 2022) and G47021 (best-use date July 21, 2022).
The FDA initiated this recall due to CGMP (Current Good Manufacturing Practice) deviations. Prior to October 1, 2021, the manufacturer's environmental and personnel monitoring procedures identified excursions in operating conditions that were not properly investigated.
Sincalide is a prescription injectable diagnostic agent. Healthcare providers and facilities should discontinue use of the affected product lots. Patients who received Sincalide from these lots should contact their healthcare provider.
The recalled product
- Product
- Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0082-00.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug
- Hazard
- cgmp-violation
- quality-assurance-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots: F24018 BUD: 6/18/2022 and G47021 BUD: 7/21/2022
Distribution
Distributed nationwide across the United States.
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