Class II Terminated

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.

This recall has been terminated (originally issued April 5, 2023).

Company: Endo Pharmaceuticals, Inc.
Recall Initiated: March 2, 2023
Posted: April 5, 2023
Recall Number: D-0475-2023
Voluntary / Mandated: Voluntary: Firm initiated
Quantity: 372,938 bottles
Firm Location: Malvern, PA, United States
Official Source: View on FDA website ↗

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.

Distribution

Nationwide in the USA and Puerto Rico

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