D-0735-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 9, 2016
- Initiation Date
- February 11, 2016
- Termination Date
- May 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 381,120 cartons
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #s: JKP2234A, JKP2235A, Exp 04/17