Calcitonin Salmon Nasal Spray Recalled for Out-of-Specification Impurities and Low Potency
Endo Pharmaceuticals is recalling Calcitonin Salmon Nasal Spray due to out-of-specification impurities and subpotent drug content. Affected lots distributed nationwide have expiration dates ranging from March 2023 to March 2025.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for out-of-specification impurities and subpotent drug. The source text does not report any illnesses or injuries. Per the severity rubric, Class II recalls without reported hospitalization are scored as High (3).
Plain-English summary
Endo Pharmaceuticals, Inc. is recalling Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL (200 IU/spray), 3.7 mL bottles. The recall involves 372,938 bottles distributed nationwide in the USA and Puerto Rico. Affected lot numbers include: 34770301 (exp. Mar-23), 34770401 (exp. May-23), 12981201 (exp. Nov-23), 13037201 (exp. Dec-23), 13037301, 13647801 (exp. Feb-24), 13722101 (exp. Mar-24), 13980101, 13980001 (exp. Apr-24), 14461701, 14461801 (exp. Jul-24), 14706201 (exp. Aug-24), 14935601 (exp. Oct-24), 5500131A, 5500132A (exp. Mar-25).
The recall was issued due to failed quality control specifications. Testing revealed high out-of-specification results for both known and unknown impurities, as well as low out-of-specification results for assay, meaning some bottles contain lower potency drug than labeled.
Patients using the recalled product should not stop taking their medication without consulting a healthcare provider. Contact Endo Pharmaceuticals or speak with a pharmacist or doctor if you have questions about whether your medication is affected by this recall.
The recalled product
- Product
- CALCITONIN SALMON (CALCITONIN SALMON)
- Brand
- CALCITONIN SALMON
- Manufacturer
- Endo Pharmaceuticals, Inc.
- Category
- Drug — Nasal Spray
- Hazard
- Affected units
- 372,938
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 (20)
- Lot #: 34770301
- exp. date Mar-23
- 34770401
- exp. date May-23
- 12981201
- exp. date Nov-23
- 13037201
- exp. date Dec-23
- 13037301
- 13647801
- exp. date Feb-24
- 13722101
- exp. date Mar-24
- 13980101
- 13980001
- exp. date Apr-24
- 14461701
- 14461801
- exp. date Jul-24
- 14706201
Distribution
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