Calcitonin Nasal Spray (Endo) – Impurity Specifications (2023)
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
Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11.
Brand
Endo Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
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, exp. date Aug-24, 14935601, exp. date Oct-24, 5500131A, 5500132A, exp. date Mar-25
Products Sold
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, exp. date Aug-24; 14935601, exp. date Oct-24; 5500131A, 5500132A, exp. date Mar-25
Endo Pharmaceuticals, Inc. is recalling Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 Internation due to Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out. 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
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
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