Class II · Moderate risk
Alendronate Sodium Tablets
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
National Drug Code
Is NDC 41616-0638-68 recalled?
Alendronate Sodium Tablets
Yes — this exact package was recalled
1 FDA recall names the code 41616-0638-68 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.
Recalls naming this package
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 41616-0758 See recall 2
- 41616-0219 See recall 1
- 41616-0760 See recall 1
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