Drug product
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.
D-0735-2016
Product summary
- Event
- Event 73420
- Status
- Terminated
- Classification
- Class II
- Quantity
- 381,120 cartons
- Official record key
drug-enforcement:D-0735-2016
Official wording
Reason: Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Code information: Lot #s: JKP2234A, JKP2235A, Exp 04/17
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications