Recalls / Class II
Class IID-1243-2015
Product
Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.
- Affected lot / code info
- Lot #: DM11774, Expiry: 6/30/2015; Lot #: DM13056, Expiry: 10/31/2015; Lot #: DM13117, Expiry: 10/31/2015; Lot #: DM13159, Expiry: 10/31/2015; Lot #: DM13186, Expiry: 10/31/2015; Lot #: DM13187, Expiry: 10/31/2015; Lot #: DM13188, Expiry: 10/31/2015; Lot #: DN10003, Expiry: 11/30/2015; Lot #: DN10045, Expiry: 11/30/2015; Lot #: DN10046, Expiry: 11/30/2015; Lot #: DN10389, Expiry: 1/31/2016; Lot #: DN10412, Expiry: 1/31/2016; Lot #: DN10604, Expiry: 1/31/2016.
Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recalling firm
- Firm
- Wockhardt Usa Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Waterview Blvd Ste 3, N/A, Parsippany, New Jersey 07054-1271
Distribution
- Quantity
- 124,034 Bottles
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2015-04-22
- FDA classified
- 2015-07-17
- Posted by FDA
- 2015-07-29
- Terminated
- 2018-05-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1243-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.