Recall D-0735-2016
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.
Recall D-0735-2016 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0735-2016 |
| Event ID | 73420 |
| Distribution | Nationwide and Puerto Rico |
| Quantity | 381,120 cartons |
| Recall Reason | Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point. |
| Drug Classification | Class II |
| Drug Code Info | 20160309 |
| Recall Initiation Date | 20160211 |
| Report Date | 20160309 |
| Termination Date | 20170523 |
| Classification Date | 20160303 |
| Address | Office # 43 Block Y Saif Zone Sharm, United Arab Emirates |
| Recalling Firm | Sun Pharma Global Fze |
| Initial Notification | |
| Similar To |