Endo Pharmaceuticals, Inc.: Drug Recall

Recall #D-0475-2023 · 03/02/2023

Class II: Risk

Recall Details

Recall Number: D-0475-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Endo Pharmaceuticals, Inc.
Status: Terminated
Date Initiated: 03/02/2023
Location: Malvern, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 372,938 bottles

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.

Product Description

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.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Other Recalls by Endo Pharmaceuticals, Inc.

Class I: Dangerous 07/10/2024

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.

View all recalls by Endo Pharmaceuticals, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.