Recalls / Class II

Class IID-1255-2015

Product

Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Affected lot / code info

A) Lot #: DM11421, Expiry: 5/31/2015; Lot #: DM12956, Expiry: 10/31/2015; Lot #: DM12957, Expiry: 10/31/2015; Lot #: DM12963, Expiry: 10/31/2015; Lot #: DM13242, Expiry: 11/30/2015; Lot #: DM13243, Expiry: 11/30/2015; Lot #: DM13251, Expiry: 11/30/2015; Lot #: DM13260, Expiry: 11/30/2015; Lot #: DN10138, Expiry: 12/31/2015. B) Lot #: DM11035, Expiry: 4/30/2015; Lot #: DM11088, Expiry: 4/30/2015; Lot #: DM11389, Expiry: 5/31/2015; Lot #: DM11393, Expiry: 5/31/2015; Lot #: DM11394, Expiry: 5/31/2015; Lot #: DM12632, Expiry: 9/30/2015; Lot #: DM12633, Expiry: 9/30/2015; Lot #: DM12650, Expiry: 9/30/2015; Lot #: DM12651, Expiry: 9/30/2015; Lot #: DM12667, Expiry: 5/31/2015; Lot #: DM12964, Expiry: 10/31/2015; Lot #: DM13086, Expiry: 10/31/2015; Lot #: DM13155, Expiry: 10/31/2015; Lot #: DM13156, Expiry: 10/31/2015; Lot #: DM13157, Expiry: 10/31/2015; Lot #: DM13158, Expiry: 10/31/2015; Lot #: DM13184, Expiry: 10/31/2015; Lot #: DM13206, Expiry: 10/31/2015; Lot #: DM13207, Expiry: 10/31/2015; Lot #: DM13266, Expiry: 11/30/2015; Lot #: DM13267, Expiry: 11/30/2015; Lot #: DM13268, Expiry: 11/30/2015; Lot #: DM13283, Expiry: 11/30/2015; Lot #: DM13325, Expiry: 11/30/2015; Lot #: DN10058, Expiry: 12/31/2015; Lot #: DN10059; Expiry: 12/31/2015; Lot #: DN10060, Expiry: 12/31/2015; Lot #: DN10061, Expiry: 12/31/2015; Lot #: DN10062, Expiry: 12/31/2015; Lot #: DN10307, Expiry: 12/31/2015; Lot #: DN10308, Expiry: 12/31/2015; Lot #: DN10324, Expiry: 12/31/2015; Lot #: DN10346, Expiry: 12/31/2015; Lot #: DN10809, Expiry: 2/29/2016; Lot #: DN10810, Expiry: 2/29/2016; Lot #: DN10840, Expiry: 2/29/2016; Lot #: DN10877, Expiry: 2/29/2016; Lot #: DN10878, Expiry: 2/29/2016; Lot #: DN10904, Expiry: 2/29/2016; Lot #: DN10905, Expiry: 2/29/2016; Lot #: DN10921, Expiry: 2/29/2016; Lot #: DN10942, Expiry: 3/31/2016; Lot #: DN10943, Expiry: 3/31/2016; Lot #: DN10972, Expiry: 3/31/2016.

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

A) 146,959 Bottles, B) 73,445 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-1255-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.