FDA-Drug2023-04-05Class II
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.
Endo Pharmaceuticals, Inc.
Hazard
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.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
372,938 bottles
Manufactured in
1400 Atwater Dr, N/A, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0475-2023Don't want to check this manually?
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