Drug product
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.
D-0526-2026
Product summary
- Event
- Event 98744
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 single dose 75 ml bottles
- Official record key
drug-enforcement:D-0526-2026
Official wording
Reason: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Code information: Lot # AC2040A, Exp Date: 04/2026
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
out of specification