Recalls / Class II
Class IID-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.
- Affected lot / code info
- Lot #s: JKP2234A, JKP2235A, Exp 04/17
Why it was recalled
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Recalling firm
- Firm
- Sun Pharma Global Fze
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- Office # 43 Block Y Saif Zone, N/A, Sharm, N/A N/A, United Arab Emirates
Distribution
- Quantity
- 381,120 cartons
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-02-11
- FDA classified
- 2016-03-03
- Posted by FDA
- 2016-03-09
- Terminated
- 2017-05-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0735-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.