FDA Drug recall D-1246-2015

Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (N…

FDA Drug
Class II
terminated
Published 2015-07-29

On 2015-07-29 the FDA classified a Class II recall of Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (N… by Wockhardt Usa, citing CGMP Deviations: Firm did not adequately investigate customer complaints.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1246-2015
Classification	Class II
Status	terminated
Initiated	2015-04-22
Published	2015-07-29
Last updated	2026-09-13 11:51 UTC
Company	Wockhardt Usa
Distribution	US

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.

Reason

CGMP Deviations: Firm did not adequately investigate customer complaints.

Identifiers

code_info	A) Lot #: DM11488, Expiry: 4/30/2015; Lot #: DM12093, Expiry: 6/30/2015; Lot #: DM12540, Expiry: 7/31/2015. B) Lot #: D… 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.

code_info

A) Lot #: DM11488, Expiry: 4/30/2015; Lot #: DM12093, Expiry: 6/30/2015; Lot #: DM12540, Expiry: 7/31/2015. B) Lot #: D…

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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1246-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.