FDA recall D-0735-2016

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.

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

Key facts

Status

Terminated

Initiation date

2016-02-11

Report date

2016-03-09

Termination date

2017-05-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sharm, N/A, United Arab Emirates

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0735-2016