Recalls / Class II
Class IID-0475-2023
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 name
- Calcitonin Salmon
- Generic name
- Calcitonin Salmon
- Active ingredient
- Calcitonin Salmon
- Route
- Nasal
- NDC
- 49884-161
- FDA application
- ANDA076979
- Affected lot / code info
- 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
Why it was recalled
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.
Recalling firm
- Firm
- Endo Pharmaceuticals, Inc.
- Manufacturer
- Endo USA, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1400 Atwater Dr, N/A, Malvern, Pennsylvania 19355-8701
Distribution
- Quantity
- 372,938 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2023-03-02
- FDA classified
- 2023-03-24
- Posted by FDA
- 2023-04-05
- Terminated
- 2024-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0475-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.