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.

FDA recall notice · announced April 5, 2023 · Endo Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

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.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: 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
Quantity: 372,938 bottles
Status: Terminated
Products in this recall event:
- 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 1097 (D-0475-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.