Endo Pharmaceuticals, Inc. recalls Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7
Recalled April 5, 2023 · FDA recall D-0475-2023 · Endo Pharmaceuticals
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. · FDA Class II
Units
372,938 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
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.
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.
Manufacturer(s)
Endo Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →