Reported Mar 9, 2016 · Terminated
Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by
Sun Pharma Global Fze
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sun Pharma Global Fze · Office # 43 Block Y Saif Zone · Sharm, N/A · N/A
Is this the product you have?
Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India |
| 2 | Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512 |
| 3 | NDC 41616-638-68, UPC 3 41616 63868 4. |
- Lot codes and dates
Lot #s: JKP2234AJKP2235AExp 04/17
- Amount recalled
- 381,120 cartons
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
This product could cause temporary or reversible health problems — stop using it.
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