FDAFDA · Food and drugs·Recall number D-0735-2016
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 41616 63868 4.
Published March 9, 2016 · Recall initiated: February 11, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Sun Pharma Global Fze
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #s: JKP2234A, JKP2235A, Exp 04/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United Arab Emirates
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