Recalls / Class II

Class IID-1246-2015

Product

Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), 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 #: DM11488, Expiry: 4/30/2015; Lot #: DM12093, Expiry: 6/30/2015; Lot #: DM12540, Expiry: 7/31/2015. B) Lot #: DM11412, Expiry: 4/30/2015; Lot #: DM11642, Expiry: 5/31/2015; Lot #: DM11682, Expiry: 5/31/2015; Lot #: DM12094, Expiry: 6/30/2015; Lot #: DM12533, Expiry: 7/31/2015; Lot #: DM12609, Expiry: 7/31/2015; Lot #: DM12898, Expiry: 9/30/2015, Lot #: DM12899, Expiry: 9/30/2015; Lot #: DN10163, Expiry: 11/30/2015; Lot #: DN10273, Expiry: 11/30/2015; Lot #: DN10487, Expiry: 12/31/2015.

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

53,894 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-1246-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.