Class II
Terminated
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.
- Company
- Sun Pharma Global Fze
- Recall Initiated
- February 11, 2016
- Posted
- March 9, 2016
- Recall Number
- D-0735-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 381,120 cartons
- Firm Location
- Sharm, United Arab Emirates
Reason for Recall
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #s: JKP2234A, JKP2235A, Exp 04/17
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