Sun Pharma Recalls Alendronate Sodium Tablets Due to Impurity Levels
Sun Pharma Global Fze is recalling specific lots of Alendronate Sodium Tablets 70 mg because unknown impurity levels exceeded specifications during stability testing.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a chemical impurity specification failure without reported injuries.
Plain-English summary
Sun Pharma Global Fze is recalling 381,120 cartons of Alendronate Sodium Tablets, USP, 70 mg. The affected product is distributed nationwide and in Puerto Rico. The specific lots involved are JKP2234A and JKP2235A, both with an expiration date of 04/17.
The recall was initiated because observed levels of the highest unknown impurity exceeded the specification limit at the 3-month stability time point. This indicates a failure to meet impurities and degradation specifications.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or supplier for disposal or replacement.
The recalled product
- Product
- Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3…
- Manufacturer
- Sun Pharma Global Fze
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 381,120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #s: JKP2234A
- JKP2235A
- Exp 04/17
Distribution
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