Warning
Hikma Pharmaceuticals USA INC Recalls Alendronate Sodium Oral Solution
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0526-2026Drug / Pharmaceutical
Hikma Pharmaceuticals USA INC Recalls Alendronate Sodium Oral Solution
Hikma Pharmaceuticals USA INC · Class II — Moderate Risk
Product Description
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.
Reason for Recall
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database