The Recall Desk
ModerateFDA (Drugs)·D-1246-2015·Announced 2015-07-29

Wockhardt Recalls Extended Phenytoin Sodium Capsules Due to CGMP Deviations

Wockhardt USA is recalling 53,894 bottles of Extended Phenytoin Sodium Capsules because the firm did not adequately investigate customer complaints.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations (inadequate complaint investigation) without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk or procedural issues.

Plain-English summary

Wockhardt USA LLC is recalling 53,894 bottles of Extended Phenytoin Sodium Capsules, USP, 100 mg. The product is available in 100-count and 1,000-count bottles and is distributed nationwide, including Puerto Rico. The recall involves specific lots with expiration dates ranging from April 30, 2015, to December 31, 2015.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. This is a Class II recall, indicating a violation of CGMPs that may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected products and contact their pharmacist or Wockhardt USA for further instructions on returns or replacements.

The recalled product

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. Parsippan
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Anticonvulsant
Hazard
Affected units
53,894

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • A) Lot #: DM11488
  • Expiry: 4/30/2015
  • Lot #: DM12093
  • Expiry: 6/30/2015
  • Lot #: DM12540
  • Expiry: 7/31/2015. B) Lot #: DM11412
  • Lot #: DM11642
  • Expiry: 5/31/2015
  • Lot #: DM11682
  • Lot #: DM12094
  • Lot #: DM12533
  • Expiry: 7/31/2015
  • Lot #: DM12609
  • Lot #: DM12898
  • Expiry: 9/30/2015
  • Lot #: DM12899
  • Lot #: DN10163
  • Expiry: 11/30/2015
  • Lot #: DN10273
  • Lot #: DN10487

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 35 recalled by Wockhardt Usa Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 35 products in this recall →

Related recalls

Same manufacturer · Wockhardt Usa Inc.

See all →

Same hazard · cgmp deviation

See all →