Calcitonin Salmon Nasal Spray Recalled for Glass Particle Defect
Apotex Corp. recalls Calcitonin Salmon nasal spray (82,375 bottles) nationwide due to a glass splinter entrapped in the pump mechanism. The defect renders the nasal spray inoperable.
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 drug recall involving a manufacturing defect (glass splinter in pump). The source does not report any injuries or illnesses. The inoperable pump prevents exposure to the foreign substance, making the hazard theoretical rather than active. This supports Moderate severity classification.
Plain-English summary
Apotex Corp. is recalling Calcitonin Salmon nasal spray (2200 USP Calcitonin Salmon Units/mL) in 3.7 mL bottles. The recall affects 82,375 bottles distributed nationwide throughout the United States.
The recall was initiated because a glass splinter particle was found entrapped inside the pump ball seat of affected bottles. This manufacturing defect renders the pump inoperable.
The affected lot is TH5645 with an expiration date of January 2025 (NDC 60505-0823-6). Patients or healthcare providers who have this medication should verify they do not have bottles from the affected lot. Patients should consult their healthcare provider before discontinuing use of this medication, as Calcitonin Salmon may be medically necessary for their condition.
The recalled product
- Product
- CALCITONIN SALMON (CALCITONIN SALMON)
- Brand
- CALCITONIN SALMON
- Manufacturer
- Apotex Corp.
- Category
- Drug — Nasal Spray
- Hazard
- glass-contamination
- device-malfunction
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 (2)
- Lot #: TH5645
- Exp. 01/2025
Distribution
Distributed nationwide across the United States.
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