D-0526-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 6, 2026
- Initiation Date
- April 7, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 single dose 75 ml bottles
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.
Distribution Pattern
US Nationwide.
Code Information
Lot # AC2040A, Exp Date: 04/2026