FDA Recall Terminated Historical recordClass II
Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
